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  • Celltrion
    Celltrion presents new two-year data for subcutaneous infliximab (CT-P13 SC) in inflammatory bowel disease (IBD) at the 19th ECCO Congress

    Results of the two-year LIBERTY studies demonstrate that CT-P13 SC provides long-term clinical benefits and safety, with the convenience of subcutaneous (SC) administration, in the treatment of moderately to severely active CD and UC1,2Data from a post-hoc analysis of the LIBERTY-CD study showed high and consistent endoscopic mucosal healing rates across all segments of the colon and terminal ileum3 February 23, 2024 06:40 AM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion today presented positive two-year results from the extended LIBERTY studies (LIBERTY-CD1 and LIBERTY-UC2) in patients with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). Celltrion also presented endoscopic outcomes from the post-hoc analysis of the LIBERTY-CD study.3These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden. Two-year results of CT-P13 SC LIBERTY studiesThe LIBERTY-CD and LIBERTY-UC studies were continued up to 102 weeks as extension phase treatments, building on the initial LIBERTY trials. The two-year studies assessed the long-term efficacy and safety of CT-P13 SC in patients with Crohn's disease (CD) and ulcerative colitis (UC), respectively.In the CT-P13 SC LIBERTY-CD study, a total of 180 patients with moderately to severely active CD entered into the extension phase up to Week 102 and received CT-P13 SC 120mg regardless of the previous assigned arm of maintenance phase. 154 (85.6%) patients completed the extension phase, and efficacy results, including clinical remission, clinical response, endoscopic remission, endoscopic response, and corticosteroid-free remission, were generally maintained at Week 102 compared to Week 54. No new safety issues were reported during the extension phase.In the CT-P13 SC LIBERTY-UC study, a total of 237 patients with moderately to severely active UC entered into the extension phase and received CT-P13 SC regardless of the previous treatment group randomized at the start of maintenance phase. The LIBERTY-UC study demonstrated sustained efficacy through Week 102, with 208 (87%) patients completing the extension phase. Clinical remission, clinical response, endoscopic-histologic mucosal improvement, and corticosteroid-free remission were generally well maintained at Week 102 compared to Week 54. No new safety concerns were observed during the extension phase.“These data reinforce the efficacy and safety profile of subcutaneous infliximab (CT-P13 SC), and demonstrate it can be used as a long-term treatment option for patients living with moderately and severely active CD and UC patients,” said Professor Jean Frédéric Colombel, Icahn School of Medicine at Mount Sinai, New York and presenting author of the poster presentation. “The combination of convenience with robust clinical data has the potential to offer benefits for patients navigating the challenges of managing IBD.” Post-hoc analysis of CT-P13 SC LIBERTY-CD studyA separate post hoc analysis investigated the pattern of endoscopic mucosal healing across intestinal segments in patients with CD receiving CT-P13 SC maintenance treatment in the Phase 3 LIBERTY-CD study.The endoscopy study led to high and consistent endoscopic mucosal healing rates across all segments up to one year, including the terminal ileum, with CT-P13 SC maintenance therapy. The rates of endoscopic complete mucosal healing and partial mucosal healing were significantly higher in the CT-P13 SC arm compared to placebo.“The early observation of mucosal healing at Week 22 showcases the potential of subcutaneous infliximab treatment in improving patient care,” said Nam Lee, Medical Director at Celltrion. “These study results capture our ongoing commitment to the IBD community and underscore our mission to improve patients’ lives by targeting diseases with high unmet needs.”A total of 32 abstracts regarding CT-P13 SC were presented at the ECCO congress. About the subcutaneous (SC) formulation of CT-P13CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.4,5 About CelltrionCelltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes 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 EMA approval for VEGZELMA® and YUFLYMA®, FDA approval for ZYMFENTRA™, and EMA 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/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.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. References1 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 (P902). Presented at ECCO 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 (P957). Presented at ECCO 2024.3 Bruce E. Sands et al., Treatment of patients with moderate-to-severe Crohn’s disease with subcutaneous infliximab leads to an endoscopic response across all segments of the colon and terminal ileum: a post hoc analysis of the LIBERTY-CD study. Poster (P983). Presented at ECCO 2024.4 Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.5 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.

  • Celltrion USA CI
    Celltrion USA completes submission of Biologics License Application for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab)

    The Biologics License Application for CT-P47 was based on Phase III data comparing CT-P47 to the reference product ACTEMRA® (tocilizumab) JERSEY CITY, N.J., Jan. 28, 2024 /PRNewswire/ -- Celltrion USA today announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product ACTEMRA® (tocilizumab)[1].The BLA submission was based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 compared to the reference product ACTEMRA® in patients with moderate to severe active rheumatoid arthritis with inadequate response to methotrexate up to Week 52."The submission of CT-P47 for review is an important step toward providing patients with rheumatoid arthritis a more accessible avenue to treatment for conditions that present such a significant disease burden," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We plan to lead the market by establishing a diverse product lineup in the autoimmune disease market in the U.S. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to people living with rheumatoid arthritis as soon as possible."ACTEMRA® is indicated for several indications, including moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous routes of administration. 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 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. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. 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 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'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 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 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. References [1] ACTEMRA® is a registered trademark of Genentech, Inc.

  • Celltrion
    Celltrion USA announces launch of additional doses for YUFLYMA® (adalimumab-aaty) in the U.S.

    YUFLYMA® (adalimumab-aaty), a high-concentration (100 mg/mL) and citrate-free formulation of HUMIRA® (adalimumab) biosimilar, is now available in 80 mg dose Celltrion USA plans to launch a 20 mg dose option in late Q1 2024 January 17, 2024, JERSEY CITY, NJ – Celltrion USA announced today the launch of an 80mg dose of YUFLYMA® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA® (adalimumab) biosimilar, in the United States. YUFLYMA is currently available in a single 40 mg dose in both a prefilled syringe with safety guard and autoinjector. The addition of an 80 mg dose will offer more choice and dosage flexibility for patients and clinical practices. YUFLYMA 80 mg is offered at the same price as YUFLYMA 40 mg to meet the needs of patients, prescribers, and payers. In addition, a 20 mg dose of YUFLYMA is expected to be available in pharmacies in late Q1 2024.More than 80% of patients treated with HUMIRA in the U.S. rely on a high-concentration and citrate-free formulation.[1] YUFLYMA is a citrate-free formulation that is highly concentrated at 100mg/mL. It also maintains stability at 25℃ (77°F) for 31 days, with protection from light, and is a latex-free device.[2] “YUFLYMA demonstrated a comparable efficacy, safety, pharmacokinetics, and immunogenicity profile as the reference product,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA.  “These new dose amounts and the auto-injector option provide flexible regimens. These new dose amount and the 2 step auto-injector option provide flexibility and convenient self-administration.”To enhance patients’ and healthcare providers’ experience using YUFLYMA, Celltrion USA offers the Celltrion CONNECT® Patient Support Program along with the Celltrion CARES™ Co-pay Assistance Program. The Patient Support Program for YUFLYMA will provide benefits verification, prior authorization assistance, and co-pay assistance. Eligible patients with private/commercial insurance may receive YUFLYMA for as little as $0 out of pocket per month. Patients who are uninsured or underinsured may be eligible to receive YUFLYMA through the Celltrion CONNECT® Patient Assistance Program (PAP). Through these support programs, nurses are available to answer patients’ questions and provide training. Visit www.CelltrionConnect.com to learn more. Notes to Editors:About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)2YUFLYMA is the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. 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. YUFLYMA is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL in July 2023 and 80mg/0.8mL in December 2023, Celltrion additionally plans to launch additional dosage form of 20mg/0.2mL in the U.S. in late 1Q 2024. YUFLYMA® IMPORTANT SAFETY INFORMATION2SERIOUS INFECTIONSPatients treated with YUFLYMA 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 YUFLYMA 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 YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA 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 YUFLYMA 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 YUFLYMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Treatment with YUFLYMA 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 YUFLYMA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with YUFLYMA, 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 YUFLYMA 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 YUFLYMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of YUFLYMA 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 YUFLYMA 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 YUFLYMA.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 adolsscents. HYPERSENSITIVITYAnaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of YUFLYMA and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATIONUse of TNF blockers, including YUFLYMA, 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 YUFLYMA 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 YUFLYMA therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONSUse of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or ra.diographic 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 YUFLYMA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of YUFLYMA should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONSRare 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 YUFLYMA therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURECases 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 YUFLYMA in patients who have heart failure and monitor them carefully. AUTOIMMUNITYTreatment 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 YUFLYMA, discontinue treatment. IMMUNIZATIONSPatients on YUFLYMA 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 YUFLYMA 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 REACTIONSThe most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONSYUFLYMA 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 RAJuvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and olderPsoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsAAnkylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active ASCrohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and olderUlcerative 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 blockersPlaque 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 appropriateHidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa  Please see full Prescribing Information for YUFLYMA® (adalimumab-aaty)  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 STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion 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'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 with respect to 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 results 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 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 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] Symphony Health, IQVIA[2] YUFLYMA U.S. prescribing information

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Celltrion

Celltrion presents new two-year data for subcutaneous infliximab (CT-P13 SC) in inflammatory bowel disease (IBD) at the 19th ECCO Congress

2024.02.24

Results of the two-year LIBERTY studies demonstrate that CT-P13 SC provides long-term clinical benefits and safety, with the convenience of subcutaneous (SC) administration, in the treatment of moderately to severely active CD and UC1,2Data from a post-hoc analysis of the LIBERTY-CD study showed high and consistent endoscopic mucosal healing rates across all segments of the colon and terminal ileum3 February 23, 2024 06:40 AM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion today presented positive two-year results from the extended LIBERTY studies (LIBERTY-CD1 and LIBERTY-UC2) in patients with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). Celltrion also presented endoscopic outcomes from the post-hoc analysis of the LIBERTY-CD study.3These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden. Two-year results of CT-P13 SC LIBERTY studiesThe LIBERTY-CD and LIBERTY-UC studies were continued up to 102 weeks as extension phase treatments, building on the initial LIBERTY trials. The two-year studies assessed the long-term efficacy and safety of CT-P13 SC in patients with Crohn's disease (CD) and ulcerative colitis (UC), respectively.In the CT-P13 SC LIBERTY-CD study, a total of 180 patients with moderately to severely active CD entered into the extension phase up to Week 102 and received CT-P13 SC 120mg regardless of the previous assigned arm of maintenance phase. 154 (85.6%) patients completed the extension phase, and efficacy results, including clinical remission, clinical response, endoscopic remission, endoscopic response, and corticosteroid-free remission, were generally maintained at Week 102 compared to Week 54. No new safety issues were reported during the extension phase.In the CT-P13 SC LIBERTY-UC study, a total of 237 patients with moderately to severely active UC entered into the extension phase and received CT-P13 SC regardless of the previous treatment group randomized at the start of maintenance phase. The LIBERTY-UC study demonstrated sustained efficacy through Week 102, with 208 (87%) patients completing the extension phase. Clinical remission, clinical response, endoscopic-histologic mucosal improvement, and corticosteroid-free remission were generally well maintained at Week 102 compared to Week 54. No new safety concerns were observed during the extension phase.“These data reinforce the efficacy and safety profile of subcutaneous infliximab (CT-P13 SC), and demonstrate it can be used as a long-term treatment option for patients living with moderately and severely active CD and UC patients,” said Professor Jean Frédéric Colombel, Icahn School of Medicine at Mount Sinai, New York and presenting author of the poster presentation. “The combination of convenience with robust clinical data has the potential to offer benefits for patients navigating the challenges of managing IBD.” Post-hoc analysis of CT-P13 SC LIBERTY-CD studyA separate post hoc analysis investigated the pattern of endoscopic mucosal healing across intestinal segments in patients with CD receiving CT-P13 SC maintenance treatment in the Phase 3 LIBERTY-CD study.The endoscopy study led to high and consistent endoscopic mucosal healing rates across all segments up to one year, including the terminal ileum, with CT-P13 SC maintenance therapy. The rates of endoscopic complete mucosal healing and partial mucosal healing were significantly higher in the CT-P13 SC arm compared to placebo.“The early observation of mucosal healing at Week 22 showcases the potential of subcutaneous infliximab treatment in improving patient care,” said Nam Lee, Medical Director at Celltrion. “These study results capture our ongoing commitment to the IBD community and underscore our mission to improve patients’ lives by targeting diseases with high unmet needs.”A total of 32 abstracts regarding CT-P13 SC were presented at the ECCO congress. About the subcutaneous (SC) formulation of CT-P13CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.4,5 About CelltrionCelltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes 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 EMA approval for VEGZELMA® and YUFLYMA®, FDA approval for ZYMFENTRA™, and EMA 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/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.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. References1 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 (P902). Presented at ECCO 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 (P957). Presented at ECCO 2024.3 Bruce E. Sands et al., Treatment of patients with moderate-to-severe Crohn’s disease with subcutaneous infliximab leads to an endoscopic response across all segments of the colon and terminal ileum: a post hoc analysis of the LIBERTY-CD study. Poster (P983). Presented at ECCO 2024.4 Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.5 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.

Celltrion USA CI

Celltrion USA completes submission of Biologics License Application for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab)

2024.01.29

The Biologics License Application for CT-P47 was based on Phase III data comparing CT-P47 to the reference product ACTEMRA® (tocilizumab) JERSEY CITY, N.J., Jan. 28, 2024 /PRNewswire/ -- Celltrion USA today announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product ACTEMRA® (tocilizumab)[1].The BLA submission was based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 compared to the reference product ACTEMRA® in patients with moderate to severe active rheumatoid arthritis with inadequate response to methotrexate up to Week 52."The submission of CT-P47 for review is an important step toward providing patients with rheumatoid arthritis a more accessible avenue to treatment for conditions that present such a significant disease burden," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We plan to lead the market by establishing a diverse product lineup in the autoimmune disease market in the U.S. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to people living with rheumatoid arthritis as soon as possible."ACTEMRA® is indicated for several indications, including moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous routes of administration. 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 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. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. 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 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'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 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 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. References [1] ACTEMRA® is a registered trademark of Genentech, Inc.

Celltrion

Celltrion USA announces launch of additional doses for YUFLYMA® (adalimumab-aaty) in the U.S.

2024.01.17

YUFLYMA® (adalimumab-aaty), a high-concentration (100 mg/mL) and citrate-free formulation of HUMIRA® (adalimumab) biosimilar, is now available in 80 mg dose Celltrion USA plans to launch a 20 mg dose option in late Q1 2024 January 17, 2024, JERSEY CITY, NJ – Celltrion USA announced today the launch of an 80mg dose of YUFLYMA® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA® (adalimumab) biosimilar, in the United States. YUFLYMA is currently available in a single 40 mg dose in both a prefilled syringe with safety guard and autoinjector. The addition of an 80 mg dose will offer more choice and dosage flexibility for patients and clinical practices. YUFLYMA 80 mg is offered at the same price as YUFLYMA 40 mg to meet the needs of patients, prescribers, and payers. In addition, a 20 mg dose of YUFLYMA is expected to be available in pharmacies in late Q1 2024.More than 80% of patients treated with HUMIRA in the U.S. rely on a high-concentration and citrate-free formulation.[1] YUFLYMA is a citrate-free formulation that is highly concentrated at 100mg/mL. It also maintains stability at 25℃ (77°F) for 31 days, with protection from light, and is a latex-free device.[2] “YUFLYMA demonstrated a comparable efficacy, safety, pharmacokinetics, and immunogenicity profile as the reference product,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA.  “These new dose amounts and the auto-injector option provide flexible regimens. These new dose amount and the 2 step auto-injector option provide flexibility and convenient self-administration.”To enhance patients’ and healthcare providers’ experience using YUFLYMA, Celltrion USA offers the Celltrion CONNECT® Patient Support Program along with the Celltrion CARES™ Co-pay Assistance Program. The Patient Support Program for YUFLYMA will provide benefits verification, prior authorization assistance, and co-pay assistance. Eligible patients with private/commercial insurance may receive YUFLYMA for as little as $0 out of pocket per month. Patients who are uninsured or underinsured may be eligible to receive YUFLYMA through the Celltrion CONNECT® Patient Assistance Program (PAP). Through these support programs, nurses are available to answer patients’ questions and provide training. Visit www.CelltrionConnect.com to learn more. Notes to Editors:About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)2YUFLYMA is the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. 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. YUFLYMA is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL in July 2023 and 80mg/0.8mL in December 2023, Celltrion additionally plans to launch additional dosage form of 20mg/0.2mL in the U.S. in late 1Q 2024. YUFLYMA® IMPORTANT SAFETY INFORMATION2SERIOUS INFECTIONSPatients treated with YUFLYMA 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 YUFLYMA 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 YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA 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 YUFLYMA 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 YUFLYMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Treatment with YUFLYMA 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 YUFLYMA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with YUFLYMA, 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 YUFLYMA 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 YUFLYMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of YUFLYMA 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 YUFLYMA 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 YUFLYMA.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 adolsscents. HYPERSENSITIVITYAnaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of YUFLYMA and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATIONUse of TNF blockers, including YUFLYMA, 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 YUFLYMA 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 YUFLYMA therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONSUse of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or ra.diographic 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 YUFLYMA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of YUFLYMA should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONSRare 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 YUFLYMA therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURECases 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 YUFLYMA in patients who have heart failure and monitor them carefully. AUTOIMMUNITYTreatment 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 YUFLYMA, discontinue treatment. IMMUNIZATIONSPatients on YUFLYMA 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 YUFLYMA 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 REACTIONSThe most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONSYUFLYMA 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 RAJuvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and olderPsoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsAAnkylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active ASCrohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and olderUlcerative 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 blockersPlaque 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 appropriateHidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa  Please see full Prescribing Information for YUFLYMA® (adalimumab-aaty)  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 STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion 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'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 with respect to 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 results 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 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 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] Symphony Health, IQVIA[2] YUFLYMA U.S. prescribing information