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European Commission approves Celltrion’s SteQeyma® (CT-P43), a biosimilar to Stelara® (ustekinumab), for the treatment of multiple chronic inflammatory diseases

SteQeyma® (CT-P43) is approved as a biologic therapy in gastroenterology, dermatology and rheumatology indications1The European Commission (EC) approval is based on the totality of evidence including the results from a Phase III study in adults with moderate to severe plaque psoriasisCelltrion is committed to expanding their biosimilar portfolio and building expertise in immunology August 26, 2024 07:57 AM INCHEON, South Korea-Celltrion today announced that the European Commission (EC) has approved the use of SteQeyma® (CT-P43), an ustekinumab biosimilar referencing Stelara®, for the treatment of multiple chronic inflammatory diseases. SteQeyma is approved as a biologic therapy in gastroenterology, dermatology and rheumatology indications.1 Stelara was the first biologic therapy for Crohn’s disease to target interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses.2 The decision from the EC follows a positive opinion recommending SteQeyma from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024.3 The EC approval of SteQeyma was based on the totality of evidence, including the results from a Phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that SteQeyma is highly similar to its reference product, Stelara, and has no clinically meaningful differences in terms of efficacy and safety.4,5 “The EC approval of SteQeyma brings an important new therapeutic option to patients and we’re excited to launch this innovative therapy, with a proven track record in Crohn’s and other immune diseases,” said Taehun Ha, Senior Vice President and Head of Europe Division at Celltrion. “This approval, alongside those of Remsima SC and Yuflyma, marks a key milestone in our strategy to strengthen Celltrion’s immunology offering, and with the recent approval of Omlyclo in May, we are looking forward to expanding our portfolio into the dermatology sector. We believe the approval demonstrates our unwavering commitment to expanding patient access to affordable, high-quality biologic medicines.” SteQeyma is Celltrion’s seventh biosimilar approved for use in the European Union (EU). Alongside Remsima® SC, a subcutaneous formulation of infliximab approved in the EU, SteQeyma joins Celltrion’s distinguished portfolio that includes Remsima® (biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab), Vegzelma® (biosimilar bevacizumab) and Omlyclo® (biosimilar omalizumab). About SteQeyma® (CT-P43, biosimilar ustekinumab)1SteQeyma®, formerly known as CT-P43, is a human IL-12 and IL-23 antagonist indicated for multiple immune-mediated diseases. SteQeyma is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. About CelltrionCelltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima®, Truxima® and Herzuma®, providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma®, Yuflyma® and Omlyclo®, FDA approval for Zymfentra®, and EC approval for Remsima® SC. To learn more, please visit www.celltrion.com/en-us. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.Although forward-looking statements contained in this presentation are based upon what management of Celltrion Inc. and its subsidiaries believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. TrademarkStelara® is a registered trademark of Johnson & Johnson.SteQeyma® is a registered trademark of Celltrion, Inc., used under license. References1 European Medicines Agency Summary of Product Characteristics (SmPC), SteQeyma.2 European Medicines Agency. Summary of Product Characteristics (SmPC), STELARA Available at: https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf. [Last accessed August 2024].3 European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024. [Last accessed August 2024].4 Papp KA et al., Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III study. BioDrugs. 2023; Available at: https://link.springer.com/article/10.1007/s40259-023-00630-5. [Last accessed August 2024].5 Papp K et al., Efficacy and Safety after Switch from Reference Ustekinumab to Ustekinumab Biosimilar (CT-P43) in comparison with the Maintenance Group (CT-P43 or Reference Ustekinumab) in Patients with Moderate-to-Severe Plaque Psoriasis: 1-Year Result. [EADV 2023, Abstract #4035]. Available at: https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Biologics-immunotherapy-targeted-therapy.pdf. [Last accessed August 2024].

2024
08
26
Celltrion USA announces incorporation of adalimumab-aaty, a Humira® biosimilar, to the Costco Member Prescription Program

 Adalimumab-aaty was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available among key distributors across the U.S. on July 2, 2023 Adalimumab-aaty's inclusion creates greater accessibility to treatments for Americans with inflammatory conditions JERSEY CITY, N.J., Aug. 12, 2024 - Celltrion USA, Inc., (Celltrion USA) today announced its FDA-approved biosimilar adalimumab-aaty, has been added to the Costco member prescription program. Adalimumab-aaty is a high-concentration (100mg/mL) and citrate-free biosimilar to Humira® (adalimumab). Adalimumab-aaty is approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa.[1] The treatment has been available in the U.S. from Costco Specialty Pharmacy on October 1, 2023 for self-funded employer plans and will now be available for all Costco members through the Costco Member Prescription Program. "We are pleased to partner with Costco, the largest warehouse club and third-largest retailer in America," said Francine Galante, Vice President of Market Access at Celltrion USA. "We are committed to increasing patient choice through access to biosimilars. The inclusion of adalimumab-aaty to the Costco Member Prescription Program will expand patients' treatment options and help reduce healthcare costs." More than 80% of patients treated with Humira in the U.S. utilize a high-concentration and citrate-free formulation. Adalimumab-aaty provides additional benefits of administration via a latex-free device and a longer shelf life due to its ability to maintain a stability at 77°F for 31 days.  The Costco Member Prescription Program is a prescription drug discount card program that provides eligible Costco members and their eligible dependents the ability to obtain lower prices on adalimumab-aaty and other participating drugs at participating pharmacies. Costco members who are uninsured and want to pay cash for their adalimumab-aaty prescription, or who have been denied coverage by their insurer, may use this program to fill their adalimumab-aaty prescriptions at a substantial savings. The pricing available through the discount card applies at Costco Specialty Pharmacies.  "Celltrion is well positioned for continued growth in the U.S. market, which will increase competition and, ultimately, access to high-quality biosimilars and biologic products at a reduced cost," said Tom Nusbickel, Chief Commercial Officer at Celltrion USA. "To further enhance patient access, we are increasing our manufacturing capacity and strengthening our supply chain resilience to ensure delivery of patient treatment." IMPORTANT SAFETY INFORMATION[1]This important safety information also applies to YUFLYMA® (adalimumab-aaty) SERIOUS INFECTIONSPatients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection.Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.  Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections. Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy. Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty with other biologic DMARDs (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. MALIGNANCYLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.  Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy. In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty. In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products. Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products. Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment. IMMUNIZATIONS Patients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONSAdalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS Crohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adultsLimitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa Please see full Prescribing Information including Boxed Warning for adalimumab-aaty Notes to Editors:About adalimumab-aaty[1]Adalimumab-aaty is an unbranded version of YUFLYMA® (CT-P17, biosimilar adalimumab).   YUFLYMA is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is FDA-approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis and Hidradenitis Suppurativa. Following the launch of 40mg/0.4mL in July 2023 and 80mg/0.8mL in December 2023, additional dosage form of 20mg/0.2mL was launched in the U.S. in March 2024. About Celltrion USACelltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd) and YUFLYMA®(adalimumab-aaty) as well as a new biologic ZYMFENTRA™. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit: www.celltrionusa.com/ FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing, "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Such Risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report. Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. TrademarksHumira is a registered trademark of AbbVie.YUFLYMA® is a registered trademark of Celltrion, Inc., used under license. References[1]  Adalimumab-aaty U.S. prescribing information

2024
08
13
Celltrion showcases promising results in phase III study for CT-P47, a biosimilar candidate of RoActemra® (tocilizumab) in patients with rheumatoid arthritis (RA) at EULAR 2024

CT-P47 was highly similar in terms of efficacy and safety to the reference product RoActemra® (tocilizumab) for the treatment of rheumatoid arthritis (RA) up to week 321High usability of the CT-P47 autoinjector (AI) was observed in RA patients, offering greater flexibility and an alternative treatment option June 13, 2024 06:01 PM Eastern Daylight TimeINCHEON, South Korea--(BUSINESS WIRE)--Celltrion today presented positive Phase III data for CT-P47, a biosimilar candidate referencing RoActemra® in patients with moderate-to-severe rheumatoid arthritis (RA), at the Annual European Congress of Rheumatology (EULAR) 2024. Data from the Phase III comparative clinical trial demonstrated that the investigational biosimilar candidate, CT-P47, has an equivalent efficacy, and comparable safety and immunogenicity profile to the reference tocilizumab product.The Phase III study randomised 471 patients with moderate to severe RA to receive either CT-P47 or reference tocilizumab every 4 weeks at a dose of 8 mg/kg for the first 20 weeks. Prior to dosing at week 24, patients receiving tocilizumab were re-randomised either to continue with reference tocilizumab or undergo transition to CT-P47 up to week 48. The primary endpoint was disease activity score 28 (DAS28) erythrocyte segmentation rate (ESR), improvement at weeks 12 and 24. The estimated differences between the two groups were -0.01 at week 12 and -0.1 at week 24, and the confidence intervals of the difference were entirely within the pre-defined equivalence margins at both timepoints (95% CI: -0.26 to 0.24 at week 12 and 90% CI: -0.30 to 0.10 at week 24). The treatment groups were highly similar in terms of mean serum concentration up to week 32, incidence of treatment emergent adverse events and anti-drug antibody positivity, demonstrating comparable pharmacokinetics, safety and immunogenicity. “Biosimilars provide an opportunity to address unmet medical needs by expanding access to high-quality biologic medicines. The positive top-line results from the Phase III study supports the biosimilarity of CT-P47 to reference tocilizumab, and also provide clinical evidence for the possibility of switching from reference tocilizumab to CT-P47,” said Dr. Josef S. Smolen, Emeritus Professor of Medicine at the Medical University of Vienna, Austria. In addition, a Phase I/III study compared pharmacokinetic (PK) similarity between the CT-P47 autoinjector (AI) and the pre-filled syringe (PFS) and evaluated the usability of the CT-P47 AI.2 The study showed PK similarity of the CT-P47 AI and the PFS in healthy subjects. In addition, higher usability of the CT-P47 AI was observed compared to the PFS in RA patients. The CT-P47 AI was well tolerated, and no new safety signals were found in the study. “We believe that administration of CT-P47 via an autoinjector presents an alternative delivery option to a pre-filled syringe in clinical practice and aims to improve treatment compliance,” said Taehun Ha, Vice President and Head of Europe Division at Celltrion. “The availability of tocilizumab biosimilars such as CT-P47 represents a great opportunity to reduce treatment costs, contributing to health-care budget sustainability, improved patient access, and lower disease burden. At Celltrion, we are always expanding our biosimilars portfolio for immunology, and we remain committed to improving the quality of patients’ lives and the sustainability of healthcare systems whilst increasing physician choice and patient access to biologics.” About rheumatoid arthritisRheumatoid arthritis (RA) is a chronic inflammatory disease that causes pain, swelling and stiffness in joints.3 Approximately 1% of the population worldwide suffer from RA4, however, the cause remains unknown. Symptoms of RA develop due to immune system dysfunction, causing immune cells to attack healthy cells, but it is currently unknown why the immune system behaves in this way. Although there's no cure for RA, early treatment such as disease-modifying anti-rheumatic drugs (DMARDs) and biological treatments can reduce the risk of joint damage and limit the impact of the condition.5 About CT-P47 (biosimilar tocilizumab)CT-P47, containing the active ingredient tocilizumab, is a recombinant humanised monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial, designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to the reference product RoActemra®, CT-P47 was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in January and February 2024 respectively. About CelltrionCelltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima®, Truxima®, Herzuma®, Yuflyma®, and Vegzelma®, and novel therapeutics such as Remsima® SC (US brand name Zymfentra®) providing broader patient access globally. To learn more, please visit www.celltrion.com/en-us. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.Although forward-looking statements contained in this presentation are based upon what management of Celltrion Inc. and its subsidiaries believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. TrademarkRoActemra® is a registered trademark of Chugai Pharmaceutical Co., Ltd., a member of the Roche Group. References1 Josef S. Smolen et al., Similar Efficacy, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate–to Severe Active Rheumatoid Arthritis: Week 32 Results from the Phase 3 Single Transition Study. Poster (POS0610). Presented at EULAR 2024.2 Edward Keystone et al., Pharmacokinetics, Usability and safety of Tocilizumab Biosimilar (CT-P47) administered subcutaneously by auto-injector or pre-filled syringe. Poster (POS0634). Presented at EULAR 2024.3 Arthritis Research UK. Rheumatoid arthritis. Available at https://www.versusarthritis.org/about-arthritis/conditions/rheumatoid-arthritis.4 Allan Gibofsky. Overview of Epidemiology, Pathophysiology, and Diagnosis of Rheumatoid Arthritis. American Journal of Managed Care. 2012;18:S295-302.5 Arthritis Foundation. Rheumatoid Arthritis. Available at https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/ [Last accessed June 2024]. NHS UK. Treatment Available at https://www.nhs.uk/conditions/rheumatoid-arthritis/treatment/.

2024
06
14
Celltrion receives European Commission approval of Omlyclo® (CT-P39), the first and only omalizumab biosimilar approved in Europe

Omlyclo® (CT-P39), used to treat allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU), becomes the first omalizumab biosimilar approved in the European UnionThe European Commission (EC) decision is based on clinical evidence, including results from a Phase III clinical trial demonstrating a comparable efficacy and safety profile with the reference product Xolair®Omlyclo® is the first omalizumab biosimilar in allergic diseases approved by the EC; the approval further bolsters the expansion of Celltrion’s biosimilar portfolio in Europe May 23, 2024 09:26 PM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion today announced that the European Commission (EC) has approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing Xolair®. Omlyclo® is approved for the treatment of allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP). The EC approval of Omlyclo® follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2024. The decision is based on clinical evidence, including results from a global Phase III clinical trial designed to evaluate the efficacy, safety and pharmacokinetics of Omlyclo® compared to the reference product Xolair® in patients with CSU up to Week 40. “For more than two decades, omalizumab, a blockbuster monoclonal antibody anti-IgE, has revolutionised the management of chronic immune-mediated inflammatory diseases,” said Professor Marcus Maurer, Professor of Dermatology and Allergy, Co-Director for the Fraunhofer Site for Immunology and Allergology of the Fraunhofer Translational Medicine and Pharmacology ITMP and Executive Director for the Institute of Allergology, Charité - Universitätsmedizin Berlin, Germany. “The development of a biosimilar of omalizumab is a welcome solution to help alleviate some challenges with treatment access. The recently approved treatment Omlyclo® has a comparable efficacy, safety and immunogenicity profile to Xolair®.” “Immunological conditions such as asthma can have a significant impact on the day-to-day lives of patients without appropriate treatment and care. This is why we are pleased to receive the first EC approval for an omalizumab biosimilar in Europe, an important step towards improving patient access to treatment. As we continue to expand our biosimilar offerings across the globe, building on our immunology and oncology product portfolio, we look forward to making a meaningful difference for patients living with immunological conditions,” said Hyoung-Ki Kim, Vice Chairman at Celltrion. Omlyclo® is Celltrion’s sixth biosimilar, besides Remsima® SC, a subcutaneous formulation of infliximab, approved for use in the EU, following the approval of Remsima® (biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab), and Vegzelma® (biosimilar bevacizumab). Omlyclo® is currently under review by the U.S. Food and Drug Administration (FDA), following the submission in March 2024. About OMLYCLO® (CT-P39, biosimilar omalizumab)Omlyclo® is the first European Commission (EC) approved anti-IgE antibody biosimilar referencing Xolair® (omalizumab). In the EU, Omlyclo® is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). About CelltrionCelltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima®, Truxima® and Herzuma®, providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma® and Yuflyma®, FDA approval for Zymfentra™, and EC approval for Remsima® SC. To learn more, please visit www.celltrion.com/en-us. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.Although forward-looking statements contained in this presentation are based upon what management of Celltrion Inc. and its subsidiaries believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. TrademarkXolair® is a registered trademark of Novartis AG.

2024
05
24
ZYMFENTRA™ (infliximab-dyyb) demonstrated long-term efficacy and safety profile of maintenance treatment through two years for adults with moderately to severely active Crohn's disease and ulcerative colitis

Findings from the extended LIBERTY studies and associated post-hoc analysis support the long-term efficacy and safety of ZYMFENTRA™, the first and only FDA-approved subcutaneous infliximab[1],[2]Data from a post-hoc analysis of the LIBERTY-CD study showed that, despite affecting drug levels, anti-drug antibodies (ADAs) status appeared to have no significant impact on W54 clinical outcomes or discontinuation rates [3] JERSEY CITY, N.J., May 21, 2024 - Celltrion USA announced today positive two-year results from the extended LIBERTY studies (LIBERTY-CD and LIBERTY-UC) for ZYMFENTRA™ (infliximab-dyyb) in adult patients with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC) after induction with intravenous (IV) infliximab, further supporting the efficacy and safety seen in previous pivotal studies. The data was shared during 18 oral and poster presentations at the Digestive Disease Week® (DDW) 2024 Annual Meeting in Washington, D.C., from May 18 to 21.  The presentations included results of the two-year LIBERTY studies and a post-hoc analysis of the LIBERTY-CD study, which evaluated the impact of anti-drug antibodies (ADAs) on drug levels and efficacy in patients treated with ZYMFENTRA. "Establishing the long-term efficacy and safety profile of ZYMFENTRA is an important step as we work to bring relief and remission to the millions of people worldwide living with Crohn's disease and ulcerative colitis," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "These studies reaffirm efficacy and tolerance of ZYMFENTRA as maintenance therapy and underscore Celltrion USA's commitment to delivering different treatment options for patients in the gastroenterology space." Two-year extension phase of LIBERTY studiesThe extension phase of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) was carried out over a duration of 102 weeks (including 10 weeks of infliximab IV induction), expanding upon the initial LIBERTY trials. These two-year studies evaluated the long-term efficacy and safety of infliximab SC in patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC). In both LIBERTY-CD and UC studies, efficacy results, including but not limited to clinical remission, clinical response and corticosteroid-free remission, were generally well maintained at Week 102 compared to those of Week 54. Post-hoc analysis of LIBERTY-CD studyA post-hoc analysis evaluated the impact of ADAs on clinical outcomes in patients with CD who received infliximab SC maintenance treatment. The analysis comprised 231 patients (ADA-positive: n=150; ADA-negative: n=81) who received infliximab SC as maintenance treatment. Notably, there were no statistically significant differences in clinical outcomes at Week 54 between ADA-positive and ADA-negative patients. Although mean trough serum infliximab concentrations at Week 54 were notably lower in the ADA-positive group than in the ADA-negative group (11.7 vs. 19.3 μg/mL; p<0.00001), both groups exceeded the historical therapeutic target concentration of 5 μg/mL, with comparable discontinuation rates observed between the groups. "Results from the two-year extension phase LIBERTY studies, alongside post-hoc analysis, highlight important data supporting the efficacy and safety of ZYMFENTRA as a subcutaneous maintenance treatment option for people living with CD and UC," said Hetal Patel, Senior Director, Medical Affairs at Celltrion USA. "The post-hoc analysis reveals that ADAs showed no significant impact on clinical outcomes or discontinuation rates. These findings could be explained by the relatively high trough serum infliximab concentrations achieved by ADA-positive patients."[1],[2],[3] PEREM long term studyIn a large multi-center prospective cohort of inflammatory bowel diseases, the study assessed SC infliximab persistence, efficacy and tolerance after the switch from intravenous infliximab. The study enrolled 426 patients, with 72.4% diagnosed with Crohn's disease (CD). At baseline, 74% of participants were receiving the standard IV infliximab dose (5 mg/kg every 8 weeks), with 16% receiving combination therapy with an immunosuppressant. Drug persistence with SC infliximab was notably high at 95.3% among patients with complete data up to Week 48 (95% confidence interval: 93.2-97.5)[4]  About Celltrion USACelltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd) and YUFLYMA®(adalimumab-aaty) as well as a new biologic ZYMFENTRA™. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit: www.celltrionusa.com. About Digestive Disease Week®Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org About ZYMFENTRA™ (infliximab-dyyb)ZYMFENTRA is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of: Moderately to severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV) and moderately to severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA (infliximab-dyyb) was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is a self-injected form of infliximab and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. ZYMFENTRA™ (infliximab-dyyb) U.S. Use and Important Safety InformationZYMFENTRA is a prescription medicine indicated in adults for maintenance treatment of:Moderately to severely active Crohn's disease following treatment with an infliximab product administered intravenously.Moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. It is not known if ZYMFENTRA is safe and effective in children under 18 years of age.What is the most important information I should know about ZYMFENTRA?SERIOUS INFECTIONSPatients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include:Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. MALIGNANCIESMalignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products.Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types.In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy.Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONSZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness). HEPATITIS B VIRUS REACTIVATIONTNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV, and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA, and monitor patients closely. HEPATOTOXICITYHepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia, and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued, and a thorough investigation of the abnormality should be undertaken. CONGESTIVE HEART FAILURECases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF. HEMATOLOGIC REACTIONCases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONSIn post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension, and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. INJECTION SITE REACTIONSIn clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. NEUROLOGIC REACTIONSAgents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop. RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTSSerious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended. RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTSConsider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. AUTOIMMUNITYTreatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop. VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTSPrior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA. ADVERSE REACTIONSIn clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA -treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD. Please click for Full U.S. Prescribing Information.Globally, prescribing information varies; refer to the individual country product label for complete information. References[1] Jean F. Colombel et al., Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease: 2 years results of the LIBERTY-CD study. Poster (Su1762). Presented at DDW 2024.[2] Bruce E. Sands et al., Subcutaneous infliximab (CT-P13 SC) for ulcerative colitis: 2-year extension results of the LIBERTY-UC study. Poster (Su1779). Presented at DDW 2024.[3] Jean F. Colombel et al., Impact of immunogenicity on clinical outcomes in patients with Crohn's disease receiving maintenance treatment with subcutaneous infliximab: A post hoc analysis of the LIBERTY-CD study. Poster (Su1765). Presented at DDW 2024.[4] Nicolas Mathieu et al., Persistence, efficacy and tolerance of subcutaneous infliximab after switch from intravenous infliximab in IBD patients in remission: one-year results from a multicenter prospective cohort. Oral Presentation (1179). Presented at DDW 2024.

2024
05
21
Notification Regarding Review Results of Merger Proposal

Dear Shareholders,   Celltrion has formed a special committee comprised of outside directors to examine whether to proceed with the merger. As part of this process, Celltrion conducted a ‘shareholder survey’, obtained an external evaluation from an accounting firm, and carried out an internal assessment with a global consulting firm.  In regard to this, we posted the notice ‘Collecting shareholder’s opinions to examine whether to proceed with the merger with Celltrion Pharm’ on our website on July 31, 2024, and conducted a shareholder survey on the potential merger from July 31 to August 12, 2024.  The results of the special committee's review, including opinions from shareholders and the decisions made by the Board of Directors, are as follows:  [Survey Results]                      Survey participation: 12,778 individuals (representing 2.5% of total shareholders), 104,431,289 shares (representing 50.6% of total issued shares).  Survey Results on the merger with Celltrion Pharm: In Favor (4.0%), Opposed (70.4%), Abstained (25.6%).       ※ As Chairman Jungjin Seo and Celltrion Holdings Co., Ltd., the major shareholders, had previously stated that          they would follow the majority opinion of shareholders after the survey ends to ensure a fair and objective survey          process, Chairman Jungjin Seo’s shares (8,268,563 shares) and Celltrion Holdings’ shares (47,644,470 shares)          were counted as opposed to the merger in the survey outcome.       ※ (Note) Survey results excluding the major shareholders: In Favor (8.7%), Opposed (36.2%), Abstained (55.1%).  [Special Committee Review Results] After conducting a comprehensive review of the shareholder survey regarding the merger, the necessity of pursuing the merger, and shareholder interests, it is deemed appropriate not to proceed with the merger at this time to protect the interests of both the company and its shareholders, despite acknowledging the potential synergies of merging with Celltrion Pharm. This decision is based on the company's commitment/policy to adequately reflect shareholder opinions and the financial burden associated with the appraisal rights. We recommended that the Board reevaluate the case once Celltrion and Celltrion Pharm can be appropriately valued.  [Board of Director Decision] Following a thorough discussion and consideration of the shareholder survey results and the special committee's review, the Board of Directors has decided not to proceed with the merger with Celltrion Pharm at this time. This decision takes into account the opposition from many shareholders and various other factors, despite the potential synergies from merging with Celltrion Pharm.Moving ahead, we will re-evaluate the merger proposal once a majority of shareholders from both companies approve the merger and when shareholder value increases for both companies. Currently, both companies will focus on their core businesses, aiming to create synergies and enhance corporate value.  Thank you.

2024
08
16
Latest Updates on Agreements with PBMs for Zymfentra

Celltrion recently informed our shareholders and analysts that we have successfully secured deals with two of the top three Pharmacy Benefit Managers (or PBMs) to include 'Zymfentra', the world's first and only subcutaneous infliximab, in their formulary. In addition, we are pleased to announce that on August 2 (EST), we successfully finalized a contract to list Zymfentra with the remaining one of the top three PBMs in the United States. As with the previous announcement, we ask for your understanding that we are unable to disclose the name of the PBM at this time due to contractual obligations. The US insurance market is divided into commercial and public insurance, and the three major PBMs handle formulary listing contracts for both types of insurance separately. Celltrion has completed formulary listing agreements for both commercial and public insurance with two of the top three PBMs, including ESI. For the remaining PBM, we have closed a deal for public insurance, leaving only the commercial insurance contract to be finalized through further negotiations. Within five months of its launch in March, Zymfentra has secured approximately 75% coverage across the entire U.S. insurance market. With this achievement, Celltrion has laid a strong foundation for the prescription growth of Zymfentra in the largest pharmaceutical market in the world.  While Celltrion is dedicated to expanding Zymfentra’s listing coverage, our focus goes beyond PBM contract closures; we are committed to turning this achievement into tangible sales.We extend our sincere gratitude for your unwavering support and confidence in Celltrion.

2024
08
05
Responses to Inquiries regarding the Inclusion of Zymfentra in PBM Formularies

Following the successful deal closure in April with Express Scripts, one of the top three PBMs, to list ‘Zymfentra’ on the formulary, Celltrion has received numerous inquiries from shareholders and analysts about the status of listing agreements with the other two PBMs.  We are pleased to announce that on July 30 , 2024(EST), we finalized a successful deal with another top-three PBM and wish to share this news preliminarily with our shareholders and analysts through our website.  While we are excited to share the details of this agreement, as provided below, we must adhere to contractual obligations, which prevent us from disclosing the name of the PBM at this time. Celltrion has signed a contract with Express Scripts to include Zymfentra, the world's first and only subcutaneous infliximab, in their formulary within two weeks of the product's launch in March. Following this agreement, we also secured a deal to list Zymfentra with another top three PBM as of July 30, 2024. In addition, Celltrion aims to sign an agreement shortly with the remaining top three PBM for the formulary inclusion of Zymfentra. This would allow Zymfentra to be listed on the formularies of all three major PBMs, which collectively cover about 80% of the US insurance market. Achieving this would provide a strong foundation for the prescription growth of Zymfentra in the largest pharmaceutical market in the world.  Our focus goes beyond PBM contract closures; we are committed to turning this achievement into actual sales. We will continue to keep you informed of related news through various channels.  We extend our sincere gratitude for your unwavering support and confidence in Celltrion.   

2024
08
01
Collecting shareholder’s opinions to examine whether to proceed with the merger with Celltrion Pharm

Dear shareholders, Greetings, Since the announcement of the merger with Celltrion Healthcare last year, we have announced through various channels that we are reviewing from multiple angles the possibility of proceeding with the second phase of the merger with Celltrion Pharm. However, various opinions and concerns have been raised by shareholders regarding the merger with Celltrion Pharm. Therefore, to practice ESG management and safeguard shareholders’ interests, we will attentively listen to our shareholders' views before deciding whether to proceed with the merger, as stated at the 33rd Annual General Meeting this March. The management has committed to fully reflecting shareholder opinions should they proceed with the merger, and given the potential financial strain from dissenting shareholders exercising their appraisal rights, which could limit the company’s future investment capabilities, it should be noted that we will carefully consider especially whether the majority of shareholders support the merger. This has never been the case in Korea, where a company gathers shareholders’ opinions and utilizes them as reference material for its decision-making before making important decisions like mergers. We have been, and will continue to be, dedicated to fostering a shareholder-friendly corporate culture.  Celltrion has formed a special committee comprised of outside directors to examine objectively whether to proceed with the merger. Under the special committee, we would like to gather feedback from shareholders as part of a comprehensive assessment on whether to proceed with the merger with Celltrion Pharm. For the previous merger with Celltrion Heatlhcare, we had set up and run a special committee to evaluate the merger. The newly established special committee will serve as the first-phase special committee to preemptively review the possibility of proceeding with the merger. Only if the decision is made to proceed with the merger will a second-phase special committee be formed to evaluate the merger at full scale, similar to the process of the previous merger with Celltrion Healthcare. The special committee will independently and objectively reflect the survey results to thoroughly assess the feasibility of the merger from various angles. Please be informed that we will decide whether to proceed with the merger, taking into account the committee’s findings, including shareholders’ opinions, as well as other pertinent factors comprehensively.  Meanwhile, in order to determine whether to proceed with the merger, reflecting shareholders’ opinions in a fair and objective manner, Chairman Jungjin Seo, the largest shareholder, and Celltrion Holdings will take a neutral position and cast their votes in accordance with the majority of shareholders' opinions as previously stated. It should be noted that both domestic and foreign institutional investors are unable to be verified through the system. As a result, their views on the merger with Celltrion Pharm will be obtained through interviews carried out by independent external agencies. Moreover, a notification regarding the collection of shareholder opinions on whether to pursue the merger with Celltrion Pharm has been sent to all shareholders, and this information is also available on the company’s website.  We kindly ask our shareholders to check the information provided in the "Disclaimer" section and the "Basic Information for Survey Participation" link below to participate in the survey and share your valuable opinions. This is how you participate in the survey. 1. Who can participate: Shareholders of Celltrion, Inc. (should be listed on the shareholder register as of June 30, 2024) 2. Survey period: Wednesday, July 31, 2024 – Monday, August 12, 2024- You can edit your survey responses until the survey ends, but please note that duplicate voting is not allowed.   The survey will be open for 24 hours from the time it is announced, except on the final day, when it will close at 5 p.m.3. How to participate:     ① Make sure to read the "Disclaimer" below and the "Basic Information for Survey Participation"(link provided below)    ② Access the survey page (link provided below)    ③ Verify yourself as a shareholder    ④ Fill out and submit the survey       ※ If individual or company investors have questions about the survey, please contact us at investor@celltrion.com.  < institutional investors and financial institutions (domestic and foreign)> Please contact the below-mentioned firms to participate in the survey. - local institutional investors: Daishin Economic Research Institute (philwha.lee@daishin.com / 02-769-3073) - foreign institutional investors: Sodali & Co (andrew.laidlaw@sodali.com / +61-2-9066-6155) 4. Link to the Basic Information for Survey Participation: https://irsurvey.celltrion.com/en/ir_surveyGuide.html 5. Link to the Survey Page: https://irsurvey.celltrion.com/en/ ※ DisclaimerPlease pay close attention to the following points regarding this survey.As of the survey date, no decisions have been made on whether to proceed with the merger or any related matters.The results of this survey are not binding on Celltrion, its board of directors, or its management. Celltrion's board of directors will ultimately decide on all matters, including the possibility of a merger with Celltrion Pharm, after careful consideration of the circumstances of the company and its industry, the rationale, and the method and timing of the merger, if needed.Therefore, the results of this survey may not align with the comprehensive review of all relevant factors, including shareholder opinions, conducted by our board of directors. In addition, this survey shall not be interpreted as making the merger with Celltrion Pharm official, nor shall it be construed as a solicitation of subscription to an issuance of new shares.

2024
07
31
Latest Developments Regarding the Agreement with PBMs for Yuflyma

Celltrion is pleased to announce the successful closure of a deal with one of the top three leading pharmacy benefit managers(PBMs) in the US for the formulary inclusion of Yuflyma, following our recent successful listing agreement for Zymfentra.  Celltrion wishes to share this news preliminarily via our website and will provide further details following our discussions with the PBM.  Celltrion has recently announced the successful closure of the deal with one of the top three PBMs in the US for the formulary inclusion of Zymfentra. Concurrently, we have finalized a listing contract for our adalimumab biosimilar Yuflyma ('Humira' as the reference product) with the same PBM. We appreciate your understanding that, at this stage, we are unable to disclose the name of the PBM.  This listing of Yuflyma marks our second contract signed with the top three PBMs, following the previous listing in OptumRx’s formulary last year. Yuflyma is estimated to have attained coverage for approximately 50% of the US insurance market (measured by the number of lives covered) solely through these two PBMs. Celltrion views the significance of this agreement from three primary perspectives.   First and foremost, it is noteworthy that Celltrion has successfully executed its pivotal strategy of 'double pricing' for the sales of Yuflyma in the US market. Celltrion places profitability as the foremost consideration in negotiations with PBMs in the overly crowded US adalimumab market. Under last year’s agreement with Optum, Celltrion provided high-WAC (Wholesale Acquisition Cost) products to the public insurance market, where the rebate proportion is lower compared to the commercial insurance market. Conversely, as evidenced in the current agreement, we have provided low-WAC products to the commercial insurance market, where the rebate proportion is relatively higher. Through this strategic approach, we have established a pricing structure aimed at optimizing profitability across the varied dynamics of the US market.This contract reflects Celltrion’s strategic move in anticipation of the Inflation Reduction Act (IRA) implications starting in 2025. The IRA mandates insurance companies to cover 60% of excess costs for medications exceeding $2,000 in annual out-of-pocket prescription costs, heralding a shift towards favoring products characterized by both low rebates and low-WAC. In a proactive move to better navigate the forthcoming regulatory landscape, Celltrion strategically secured a competitive edge by including low-WAC and low-rebate products in industry-leading PBMs' formularies. The advantage of a low WAC extends beyond reduced out-of-pocket costs for patients—it also facilitates more favorable rebate negotiations with insurers, thereby strengthening Celltrion's profitability. Another significant aspect of this PBM contract is its facilitation of a strategic bundling of Zymfentra and Yuflyma for U.S. IBD specialists. The inclusion of Yuflyma in commercial plans expands options with an equally safe and effective biosimilar to Humira, complemented by Zymfentra, which presents an innovative approach for IBD treatment as the world's first and only subcutaneous infliximab. The anticipated rollout of the Stelara biosimilar, CT-P43, is expected to further solidify Celltrion's position in the IBD treatment landscape, driving prescription growth across its portfolios through enhanced market preference and cross-selling synergies. Furthermore, this agreement lays a robust groundwork for Celltrion to broaden the target market for Yuflyma into rheumatoid arthritis (RA), another significant indication of adalimumab, starting in the year’s second half. This enabled Yuflyma to target the entire Humira’s US market, valued at $18.62 billion (approximately KRW 24.2 trillion, as of 2022).  Celltrion remains dedicated to expediting contracts with the remaining major PBM and extending its efforts to medium and small-sized PBMs. By the year's first half, the company is determined to implement all necessary measures to gear itself for a quantum jump this year in the world's largest pharmaceutical market. Under the leadership of Chairman Jungjin Seo, the Celltrion team is fully engaged in ongoing sales endeavors across the U.S. to ensure that not only the company’s flagship product, Zymfentra, but also Yuflyma, Vegzelma, and its entire product portfolio achieve notable sales success.  Celltrion remains committed to maintaining timely communication channels with its shareholders. 

2024
04
11