Celltrion

 EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) Celltrion plans to enter the U.S. ophthalmology market to meet diverse needs of patients suffering from various eye conditions INCHEON, South Korea, Oct. 9, 2025 - Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).[1] Aflibercept is a VEGF inhibitor formulated as an injection for the eye that blocks the growth of new blood vessels and decreases the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved in ocular angiogenesis. "Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have EYDENZELT approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the U.S.," said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "With EYDENZELT demonstrating biosimilarity to its reference product, we believe this approval will mark a significant milestone in the treatment landscape of retinal diseases—helping physicians broaden their options and improving patient outcomes." The FDA approval was based on a totality of evidence including analytical, nonclinical, and clinical data. In a randomized, double-masked, parallel-group, multicenter phase III study of EYDENZELT, the efficacy, safety, pharmacokinetics, and immunogenicity of EYDENZELT was compared to EYLEA in patients with diabetic macular edema (DME). The 52-week trial included 348 patients with DME. The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, comparing EYDENZELT and EYLEA. 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. "Advanced age-related macular degeneration (AMD) is a leading cause of irreversible blindness and visual impairment in the world and nearly 20 million people in the U.S. are living with some form of age-related macular degeneration," said Dr. David M. Brown, Director, Retina Consultants of Texas Research Centers, Co-chair, Medical Leadership Board Retina Consultants of America. "EYDENZELT will be an important new addition to our options for the treatment of our patients with serious retinal diseases." EYDENZELT is Celltrion's first FDA-approved biologic product in ophthalmology. EYDENZELT was also approved by the European Commission (EC) in February 2025.   ### About EYDENZELT® ( aflibercept-boav ) EYDENZELT® (aflibercept-boav) is a vascular endothelial growth factor (VEGF) inhibitor referencing EYLEA® (aflibercept). EYDENZELT is approved based on a comprehensive data confirming the therapeutic equivalence EYLEA. In the U.S., EYDENZELT is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). INDICATIONSEYDENZELT® (aflibercept-boav) is indicated for the treatment of patients with:Neovascular (Wet) Age-Related Macular Degeneration (AMD)Macular Edema Following Retinal Vein Occlusion (RVO)Diabetic Macular Edema (DME)Diabetic Retinopathy (DR) IMPORTANT SAFETY INFORMATIONEYDENZELT is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, and hypersensitivity to aflibercept or any of the excipients in EYDENZELT.Instruct patients and/or caregivers to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including aflibercept products. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. For more information, see Full Prescribing Information . About Celltrion , Inc.Celltrion, Inc. 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, hematology, 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. 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 ten biosimilar products approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). 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, and stay updated with our latest news and events on our social media: LinkedIn. 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 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 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 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. TrademarksEYDENZELT® is a registered trademark of Celltrion, Inc.EYLEA® is a registered trademark of Regeneron Pharmaceuticals Inc. References[1] EYDENZELT U.S. prescribing information (2025) US--24-00028

Switching from intravenous (IV) to subcutaneous (SC) infliximab was shown to be well tolerated, with a low relapse risk for most IBD patients and high treatment persistence1, 2 INCHEON, South Korea – Celltrion, Inc. today showcased real-world evidence supporting the use of subcutaneous (SC) infliximab, confirming the efficacy and safety of switching to SC infliximab 120mg every two weeks in patients with inflammatory bowel disease (IBD). The real-world evidence was presented at the Meet the Expert (MTE) Sessions at UEG 2025, and included presentations from Professor Nicolas Mathieu, Medical Director of MICI Institut Privé, Cliniques des Cèdres and Associate Professor of Gastroenterology, and Prof Anthony Buisson, Head of IBD Unit at University Hospital Estaing, Clermont Ferrand, France. Professor Nicolas Mathieu presented a real-life study which demonstrated that the switch from IV infliximab to SC infliximab is well tolerated amongst patients. The presentation particularly highlighted the results from the multicentric, prospective PEREM real-life cohort study, which found high treatment persistence, with more than 95% of patients in remission remaining on therapy after one year in real-world practice.1 In addition, there was no significant difference of SC infliximab persistence at Week 48 between patients who were on combination therapy with immunomodulator at both inclusion and 3 months and those on SC infliximab monotherapy.2 In Professor Anthony Buisson’s session, it was shared that patients switching from IV to SC infliximab is feasible and safe, even in challenging cases such as obesity, prior perianal disease, or patients with complicated phenotypes (structuring or fistulizing CD). Long term persistence of SC infliximab was also confirmed in multiple studies across the UK and France, and was generally considered effective, safe, and well accepted, with low relapse risk in most IBD patients. SC infliximab also showed promising efficacy after IV induction in patients with active perianal lesions.1 “The Meet the Expert sessions provide an important opportunity to share real-world evidence on the role of subcutaneous infliximab,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “The evidence confirms that switching from intravenous to subcutaneous therapy is effective and safe and supports more sustainable healthcare delivery.” Notes to Editors: 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.3,4 In July 2024, CT-P13 SC received final approval from the European Commission for an additional dosing regimen and dose escalation, which allows 3-IV induction dosing regimen and dose escalation of subcutaneous maintenance dose from CT-P13 SC 120 mg Q2W to 240 mg Q2W for patients with loss of response.5 Long term data from two-year extension of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) have demonstrated sustained efficacy and safety of CT-P13 SC, with clinical remission, response, and corticosteroid-free remission generally maintained through Week 102.6 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. 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", “anticipates”, 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. References1 Buisson A et al. Clinical Gastroenterology and Hepatology 2023; Buisson A et al. Alimentary Pharmacology and Therapeutics 20232 Mathieu N et al., Persistence and Safety of Subcutaneous Infliximab 1 Year After Switch From Intravenous Route in IBD Patients in REMission. Clinical Gastroenterology and Hepatology. 20253 Schreiber S et al., Gastroenterology. 2021;160(7):2340-23534 Westhovens R et al., Rheumatology. 2021;60(5):2277-22875 European Medicines Agency Summary of Product Characteristics (SmPC), Remsima®. Available at link to SmPC [Last accessed October 2025].6 Colombel JF et al., Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Crohn’s Disease and Ulcerative Colitis: 2-Year Results from Open Label Extensions of Two Randomized Controlled Trials (LIBERTY). Journal of Crohn’s and Colitis. 2025;19(6):jjaf060

The AVTOZMA ® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as the reference product ACTEMRA ® (tocilizumab)AVTOZMA is Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDAThis launch strengthens Celltrion's immunology portfolio beyond tumor-necrosis factor (TNF)-alpha and interleukin (IL)-12 and 23 inhibitors, to include an IL-6 inhibitor , broadening coverage across multiple inflammatory pathways and addressing a wider spectrum of diseases and patient populations INCHEON, South Korea, Oct. 2, 2025  -- Celltrion, Inc. today announced that AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation is now available to patients in the United States. AVTOZMA IV is approved for all same indications as the reference product Actemra®  (tocilizumab), including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA), coronavirus disease (COVID-19) and cytokine release syndrome (CRS).[1] AVTOZMA IV will be available in all the same formulations currently provided by ACTEMRA IV. The available presentations are 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) in single-dose vials. "Immune-mediated conditions such as rheumatoid arthritis have profound impact on patients' daily lives," said Prof. Gerd-Rüdiger Burmester, MD, Professor of Medicine and Rheumatology, Senior Professor in the Department of Rheumatology and Clinical Immunology at Charité - Universitätsmedizin Berlin, Germany. "The availability of a tocilizumab biosimilar gives physicians additional options to manage the disease and maintain continuity of care, which is a welcome news for both patients and clinicians." "The launch of AVTOZMA IV reinforces Celltrion's strong commitment to providing physicians and patients with access to high-quality treatment options for serious immune-mediated diseases and to supporting the sustainability of the U.S. healthcare system," said Thomas Nusbickel, Chief Commercial Officer of Celltrion USA. "It also strengthens our immunology portfolio, expanding beyond TNF-α and IL-12/23 inhibitors, now including an IL-6 inhibitor, broadening coverage across inflammatory pathways and enhancing our ability to address a broader range of patient needs." At launch, AVTOZMA IV will be supported by a comprehensive patient support resources for healthcare providers and patients, and copay support for eligible commercial patients prescribed AVTOZMA IV. Notes to Editors: About AVTOZMA ®  (CT-P47, tocilizumab-anoh)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 received approval from the U.S. Food and Drug Administration (FDA) and European Commission (EC) in January and February 2025, respectively. In July 2025, the FDA approved an additional indication for the intravenous (IV) formulation of AVTOZMA for the treatment of cytokine release syndrome (CRS) in adult and pediatric patients aged two years and older.  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.Cytokine Release Syndrome (CRS): Adults and pediatric patients 2+ years-old with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndromeCOVID-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 INFECTIONSAVTOZMA ® 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.Hepatotoxicity . 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 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, hematology, 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. 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's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). 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 and stay updated with our latest news and events on our social media - LinkedIn. 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", "anticipates", 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 (2025)