Celltrion

Post-hoc analyses at ECCO 2025 build on pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) which has previously demonstrated superior efficacy of subcutaneous (SC) infliximab (CT-P13 SC) over placebo in moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC)1,2New data highlights the effectiveness of SC infliximab in achieving endoscopic-histologic remission in UC and clinical and endoscopic improvement in CD across all disease locations3,4Further insights on rapid clinical recapture following dose escalation of SC infliximab after loss of response and long-term drug persistence in CD regardless of anti-drug antibodies (ADA) occurrence highlights the robustness of SC infliximab in IBD management5,6 February 20, 2025 11:45 AM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion announced new post-hoc analyses of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), at the 20th European Crohn’s and Colitis Organisation (ECCO) Congress showcasing the treatment’s effectiveness across a range of key clinical outcomes in inflammatory bowel disease (IBD). The analyses highlight Celltrion’s ongoing efforts to evaluate the efficacy and safety of subcutaneous (SC) infliximab (CT-P13 SC) in achieving endoscopic-histologic remission in ulcerative colitis (UC), clinical and endoscopic improvement across all disease locations in Crohn’s disease (CD), and supporting early clinical recapture after dose escalation following loss of response in CD and UC, and long-term drug persistence regardless of ADA in CD patients.3,4,5,6 LIBERTY-UC Phase III Post-Hoc Analysis (LIBERTY-UC Endo-Histological Outcome)A post-hoc analysis of the Phase 3 LIBERTY-UC study showed that maintenance therapy with SC infliximab resulted in significantly greater improvements in endoscopic and histologic outcomes at Week 54 compared to placebo. Endoscopic improvements were observed as early as Week 8, along with enhancements in stringent endpoints such as endoscopic normalisation and the combined endpoint of histologic remission and endoscopic normalisation over time, supporting the sustained benefit of a maintenance therapy with SC infliximab.Endoscopic improvements were observed in half of the patients in both groups at week 8. However, from Week 22 onwards, the difference in rates of endoscopic improvement between the two groups was statistically significant, with SC infliximab showing higher rates (50.7% vs 34.0%; p=0.0011) up to Week 54 (43.9% vs 22.2%; p<0.0001). Similar findings were observed for histologic remission. Endoscopic normalisation rate in the SC infliximab group increased with continued treatment while it declined in the placebo group (23.8% vs 21.5% at Week 8; 26.9% vs 18.8% at Week 22; 32.7% vs 11.1% at Week 54). Furthermore, a greater proportion of patients in the SC infliximab group achieved combined histologic remission and endoscopic normalisation compared to the placebo group from Week 22 up to Week 54 (22.1% vs 16.7% at W22; p=0.2072; 27.9% vs 11.1% at W54; 51 p<0.0001).3 LIBERTY-CD Phase III Post-Hoc Analysis (LIBERTY-CD Disease Location)A post-hoc analysis of the Phase 3 LIBERTY-CD study examined the efficacy of SC infliximab in patients according to disease locations (ileal, ileocolonic or colonic).The finding shows SC infliximab maintenance therapy was effective across all disease locations with statistically significant higher rate of endoscopic response at Week 54 compared to placebo. At Week 54, patients receiving SC infliximab maintenance therapy achieved a significantly higher numerical and/ or statistical clinical remission rate compared to placebo across all disease locations (ileal: 45.5% vs 16.7%, P=0.065; ileocolonic: 68.1% vs 48.5%, P=0.083; colonic: 67.0% vs 29.1%, P<0.001). A greater proportion of patients who received SC infliximab achieved endoscopic response than those who received placebo across all disease locations (ileal: 36.4% vs 5.6%, P=0.019; ileocolonic: 61.1% vs 27.3%, P=0.006; colonic: 52.5% vs 18.2%, P<0.001). Patients who achieved both clinical remission and endoscopic response at Week 54 showed similar proportional differences between SC infliximab and placebo, irrespective of disease location (ileal: Δ30.3%, P=0.009; ileocolonic: Δ32.7%, P=0.003; colonic: Δ35.7%, P<0.001).4 Additional Post-Hoc AnalysesA separate post-hoc analysis on dose escalation in both UC and CD patients (LIBERTY-CD & UC Dose Escalation) found that dose escalation with SC infliximab after loss of response (LoR) resulted in rapid clinical recapture in both CD and UC patients, with significantly elevated serum infliximab levels in early recapturers.5Finally, a post-hoc analysis from LIBERTY-CD study (LIBERTY-CD 2Y Immunogenicity) examined the role of anti-drug antibodies (ADA) in patients treated with SC infliximab. The analysis shows that despite the occurrences of ADAs, there was no significant impact on drug persistence and clinical efficacy up to and including Week 102.6“The combined achievement of both endoscopic and histologic remission is an emerging therapeutic target in ulcerative colitis (UC), and it has been associated with lower clinical relapse rates and reduced corticosteroid use,” said Professor Jean Frédéric Colombel, Icahn School of Medicine at Mount Sinai, New York and presenting author of the digital oral presentation. “It is encouraging to see more treatment options such as subcutaneous infliximab, that can help achieve these important goals. This is a positive step forward, as these outcomes contribute not only to better disease control but also to improved long-term prognosis and quality of life for patients.”“We are pleased to present important data points, including the impact of SC infliximab on achieving endoscopic and histologic remission in UC, as well as insights into dose escalation after loss of response in IBD,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “These findings provide valuable evidence to support physicians in clinical practice and reinforce our commitment to enhancing treatment options and improving patient outcomes.” 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.7,8 About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. 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 results expressed or implied by such forward-looking 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. 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. Available at: https://www.gastrojournal.org/article/S0016-5085(24)02326-6/abstract [Last accessed February 2025]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. Available at: https://www.gastrojournal.org/article/S0016-5085(24)02343-6/pdf [Last accessed February 2025]3 Jean F. Colombel et al., Endoscopic and histologic outcomes in patients with moderate-to-severe ulcerative colitis treated with infliximab: A post hoc analysis of the Phase 3 LIBERTY-UC study. Digital Oral Presentation (DOP 001). Presented at ECCO 2025. Available at: https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i77/7967018 [Last accessed February 2025]4 Stefan Schreiber et al., Efficacy of subcutaneous infliximab maintenance therapy according to disease location in patients with moderate-to-severe Crohn’s disease: A post hoc analysis of the Phase 3 LIBERTY-CD study. Poster (P0702). Presented at ECCO 2025. Available at: https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i1374/7967805 [Last accessed February 2025]5 Marla C. Dubinsky et al., Time to clinical recapture after dose escalation of subcutaneous Infliximab (CT-P13 SC) following loss of response: A post hoc analysis of the 2-year Phase 3 LIBERTY-CD & LIBERTY-UC trials. Poster (P1142). Presented at ECCO 2025. Available at: https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i2091/7971751 [Last accessed February 2025]6 Bruce E. Sands et al., Impact of immunogenicity on 2-year clinical outcomes in patients with moderate-to-severe Crohn’s disease treated with subcutaneous infliximab: A post hoc analysis of the Phase 3 LIBERTY-CD study. Poster (P0638). Presented at ECCO 2025. Available at: https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i1255/7967790 [Last accessed February 2025]7 Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.8 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.

Celltrion gains simultaneous regulatory approval of two monoclonal antibody biosimilars across three treatments – Eydenzelt® (aflibercept), Stoboclo® and Osenvelt® (denosumab) in the EU marketEuropean Commission approval based on totality of evidence including extensive comparative analytical, pharmacokinetic and clinical dataThe company expands its biosimilar portfolio to 11 in 2025 as planned, further strengthening its commitment to a portfolio of 22 drugs by 2030 February 18, 2025 09:57 PM Eastern Standard Time INCHEON, South Korea--Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt® (CT-P42, aflibercept), a biosimilar to Eylea® to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV); and Stoboclo® and Osenvelt® (CT-P41, denosumab), biosimilars referencing Prolia® and Xgeva® used for all indications of the reference products. The EC approval expands Celltrion’s diverse biosimilars portfolio across multiple therapeutic areas such as skeletal-related disorders and ophthalmology. “Celltrion is committed to expanding access to high-quality monoclonal antibody treatments for patients across Europe,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “Securing regulatory approval for three biosimilar products on the same day highlights our commitment to providing healthcare professionals with reliable, effective, and accessible treatment options for their patients. With a portfolio of 11 biosimilar brands and a fully integrated approach—from research and development to manufacturing and direct supply—Celltrion is increasing treatment options, improving patient access to biologics, and strengthening its role as a trusted partner for healthcare professionals in Europe, all while supporting the sustainability of healthcare systems.” Data showed that Eydenzelt® (40 mg/mL solution for injection in vial and pre-filled syringe), Stoboclo® (60 mg solution for injection in pre-filled syringe) and Osenvelt® (120 mg solution for injection in vial) have comparable quality, safety and efficacy when compared to their respective reference products, Eylea® (aflibercept) and Prolia® and Xgeva® (denosumab), respectively. 1,2,3 “The European Commission approval of Eydenzelt®, Stoboclo® and Osenvelt® are a significant milestone and a welcome addition to our portfolio of medicines to address a significant unmet need in therapeutic areas including skeletal-related disorders and ophthalmology,” said Min Kyoung Jeon, Vice President and Head of Regulatory Affairs Division at Celltrion. “The approval highlights Celltrion’s continuous commitment to expanding the availability, access and uptake of these important treatment options to patients with unmet needs.” The company’s therapeutics include a total of 11 biosimilar products: 4 immunology products, including Remsima®/Inflectra® (US), Remsima® SC, Yuflyma®, and SteQeyma®; 3 oncology products, including Truxima®, Herzuma®, and Vegzelma®; and other therapeutic areas, including Omlyclo®, Eydenzelt®, Stoboclo® and Osenvelt®. About CT-P41 Phase III Clinical TrialThe Phase III study randomised 479 patients to receive 60 mg of CT-P41 or reference product every six months (Weeks 0 and 26; treatment period [TP] I). Results of the study showed that CT-P41 had equivalent efficacy and pharmacodynamics to reference denosumab, with similar pharmacokinetic and comparable safety and immunogenicity profiles.3 About CT-P42 Phase III Clinical TrialIn a randomised, double-masked, parallel-group, multi-centre Phase III study of Eydenzelt® (CT-P42), the efficacy, safety, pharmacokinetics, usability and immunogenicity of Eydenzelt® was compared to Eylea® (aflibercept) in patients with diabetic macular edema (DME). Results of the study showed that Eydenzelt® met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to Eylea®.1,2 About Stoboclo® (CT-P41, biosimilar denosumab)Stoboclo® (denosumab), a receptor activator of NF-κb ligand (RANKL) inhibitor, is a treatment developed as a biosimilar to reference product Prolia® (denosumab). In Europe, Stoboclo® has been approved to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.4 Stoboclo® was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA). About Osenvelt® (CT-P41, biosimilar denosumab)Osenvelt® (denosumab) is a receptor activator of NF-κb ligand (RANKL) inhibitor developed as a biosimilar referencing Xgeva® (denosumab). Osenvelt® has been approved in Europe to prevent skeletal-related events in adults with advanced malignancies involving bone, and to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.5 Osenvelt® was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA). About Eydenzelt® (CT-P42, biosimilar aflibercept)Eydenzelt® (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea®. Based on comprehensive data from a Phase III clinical trial confirming therapeutic equivalence to Eylea®3, Eydenzelt® is approved to treat neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV).6 Eydenzelt® was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA). About CelltrionCelltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. 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 results expressed or implied by such forward-looking 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. Trademarks Stoboclo® and Osenvelt® are registered trademarks of Celltrion Inc.Prolia® and Xgeva® are registered trademarks of Amgen Inc. Eydenzelt® is a registered trademark of Celltrion Inc.Eylea® is a registered trademark of Bayer AG. References_____________________________________1 Sebastian Wolf et al., Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42 3.1. [EURETINA 2024, Abstract #CA24-2257-8397]. Available at: https://abstracts.euretina.org/2024/ca24-2257-8397/r/recxUD7DqYfFfjC7s [Last accessed February 2025].2 Sebastian Wolf et al., Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study. Available at: https://www.sciencedirect.com/science/article/pii/S2468653024003063 [Last accessed February 2025].3 Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed.ncbi.nlm.nih.gov/39042292/ [Last accessed February 2025].4 European Medicines Agency Summary of Product Characteristics (SmPC), Stoboclo. [Last accessed February 2025].5 European Medicines Agency Summary of Product Characteristics (SmPC), Osenvelt. [Last accessed February 2025].6 European Medicines Agency Summary of Product Characteristics (SmPC), Eydenzelt. [Last accessed February 2025].

The intravenous (IV) formulation of AVTOZMA® (tocilizumab-anoh) is expected to be available in the U.S. in August 2025Approval was received for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19[1]AVTOZMA® becomes Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDA JERSEY CITY, N.J., Jan. 30, 2025 -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA®. AVTOZMA is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19).[1] "Introducing both IV and SC formulations of AVTOZMA provides flexibility and a wider range of treatment options," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs." The FDA's decision is based on a comprehensive data package and the totality of evidence, including the results from a phase III study demonstrating biosimilarity between AVTOZMA and reference tocilizumab in patients with moderate to severe active RA. The primary endpoint was met in terms of change from baseline in disease activity score using 28 joints (DAS28)-ESR at Week 24, and the final 1-year results supported comparability in secondary efficacy, pharmacokinetic (PK), safety and immunogenicity results between AVTOZMA and reference tocilizumab. The clinical results demonstrated that AVTOZMA and its reference tocilizumab are highly similar and have no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics (PK) and immunogenicity.[2] In accordance with the patent settlement agreement with Genentech, the intravenous (IV) formulation of AVTOZMA® (tocilizumab-anoh) is expected to be available in the U.S. in August 2025. Celltrion has a license to market the subcutaneous formulation in the U.S. commencing on the license date, which remains confidential. AVTOZMA is Celltrion's seventh biosimilar granted marketing authorization in the U.S. About AVTOZMA® (tocilizumab-anoh)[1] AVTOZMA® (tocilizumab-anoh), containing the active ingredient tocilizumab, is a recombinant humanized 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 reference tocilizumab, AVTOZMA 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.   INDICATION AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).Giant Cell Arteritis (GCA): Adult patients with GCA.Polyarticular Juvenile Idiopathic Arthritis (pJIA): Patients 2+ years-old with active pJIA.Systemic Juvenile Idiopathic Arthritis (sJIA): Patients 2+ years-old with active sJIA.COVID-19: Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS INFECTIONS AVTOZMA® and other tocilizumab products may increase the risk of serious infections, potentially leading to hospitalization or death, especially in patients using concurrent immunosuppressants. If a serious infection develops, interrupt AVTOZMA until the infection is controlled. Reported infections include:Active tuberculosis (TB) which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during treatment (except in COVID-19 patients) and treat latent infections before starting AVTOZMA.Invasive fungal infections: Such as candidiasis, aspergillosis, and pneumocystis, may present as disseminated rather than localized disease.Opportunistic infections, including bacterial, viral and other opportunistic pathogens. Monitor patients for signs of infection, including TB, during and after AVTOZMA treatment.Contraindications: Known hypersensitivity to tocilizumab products.Serious Infections. Serious and sometimes fatal infections have been reported with AVTOZMA. Do not use during active infections, including localized infections. Discontinue AVTOZMA if a serious infection occurs and resume only once controlled.Gastrointestinal (GI) Perforation. Gastrointestinal perforations, often linked to diverticulitis, have been reported with tocilizumab. Use AVTOZMA cautiously in high-risk patients and promptly evaluate new abdominal symptoms for early detection and management.Hepatoxicity. Monitor for hepatic injury signs. Avoid AVTOZMA if ALT/ AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19); discontinue if ALT/AST >5x ULN or symptoms of liver disease develop.Changes in Laboratory Parameters. Monitor neutrophils, platelets, liver enzymes, and lipids due to potential treatment-related changes; avoid initiating AVTOZMA in patients with critically low ANC or platelet counts.Immunosuppression. The impact of AVTOZMA on malignancy development is unknown, but it may increase risk as an immunosuppressant.Hypersensitivity Reactions, including anaphylaxis, and death, have occurred; administer IV infusions with anaphylaxis management support, discontinue permanently if reactions occur, and avoid use in patients with known hypersensitivity.Demyelinating Disorders. The impact of tocilizumab on demyelinating disorders is unknown, but rare cases were reported; monitor symptoms and use caution with preexisting or recent disorders.Active Hepatic Disease and Hepatic Impairment. Treatment with AVTOZMA is not recommended.Live Vaccines. Avoid concurrent use with AVTOZMA.Adverse Reactions (≥5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, elevated ALT, and injection site reactions. For more information, see Full Prescribing Information. 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. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries. Celltrion has seven biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), STEQEYMA® (ustekinumab-stba), and AVTOZMA® (tocilizumab-anoh), as well as novel biologic ZYMFENTRA® (infliximab-dyyb). For more information, please visit https://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. This press release contains forward looking statements. These statements may be also 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 associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, 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 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. TrademarksAVTOZMA® is a registered trademark of Celltrion Inc.ACTEMRA® is a registered trademark of Chugai Pharmaceutical Co., Ltd.  References[1] AVTOZMA U.S. prescribing information (2024)[2] Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. Available at: https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ [Last accessed December 2024]