Tocilizumab-anoh

FDA approval of OMLYCLO® (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases OMLYCLO® (omalizumab-igec) is the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab); The FDA previously approved OMLYCLO® 75 mg/0.5 mL and 150 mg/mL in a single-dose prefilled syringe for subcutaneous injection in March 2025 FDA approval of OMLYCLO® (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases OMLYCLO® (omalizumab-igec) is the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab); The FDA previously approved OMLYCLO® 75 mg/0.5 mL and 150 mg/mL in a single-dose prefilled syringe for subcutaneous injection in March 2025 INCHEON, South Korea, Dec. 1, 2025 -- Celltrion, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO® (omalizumab-igec), the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., OMLYCLO will be marketed and distributed exclusively by Celltrion USA, Inc. In March 2025, the FDA approved OMLYCLO in 75 mg/0.5 mL and 150 mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).[1] "The approval of the additional 300 mg presentation of OMLYCO underscores our dedication to patients in the U.S., by broadening treatment choices and expanding flexibility, addressing diverse needs of patients with allergic and inflammatory conditions," said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "The new dosing option of OMLYCLO can help reduce the number of required injections and ease the overall treatment burden and discomfort for patients with these diseases." "We are proud of the expansion of OMLYCLO's dosing options, marking another significant milestone in our commitment to increasing access to biologic treatments in the U.S.," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We remain steadfast in our efforts to support physicians with flexible, high-quality treatment options and ensure that more patients can benefit from best-in-class care." ### About OMLYCLO® (omalizumab-igec) OMLYCLO® (omalizumab-igec) is the first U.S. Food and Drug Administration (FDA)-approved anti-IgE antibody biosimilar referencing XOLAIR® (omalizumab). OMLYCLO 75 mg/0.5 mL, 150 mg/mL and 300 mg/2mL solutions in a single-dose prefilled syringe is approved as interchangeable with the reference product for all indications based on comprehensive data and clinical evidence confirming the therapeutic equivalence to XOLAIR.[1] OMLYCLO was approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in March 2025 and May 2024, respectively. INDICATION OMLYCLO® (omalizumab-igec) injection, is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients ≥18 years of age with inadequate response to nasal corticosteroids, as add-on maintenance treatment IgE-mediated food allergy in adult and pediatric patients aged ≥1 year age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance Chronic spontaneous urticaria (CSU) in adults and adolescents ≥12 years of age who remain symptomatic despite H1 antihistamine treatment Moderate to severe persistent asthma in adults and pediatric patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients ≥18 years of age with inadequate response to nasal corticosteroids, as add-on maintenance treatment IgE-mediated food allergy in adult and pediatric patients aged ≥1 year age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance Chronic spontaneous urticaria (CSU) in adults and adolescents ≥12 years of age who remain symptomatic despite H1 antihistamine treatment Limitations of Use: Not indicated for: acute bronchospasm or status asthmaticus; emergency treatment of allergic reactions, including anaphylaxis; other forms of urticaria. IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration. Health care providers administering OMLYCLO should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis. Contraindications: Severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO. Anaphylaxis. Omalizumab products, including OMLYCLO, have been associated with anaphylaxis, reported in both clinical trials and postmarketing data. Patients with a history of anaphylaxis to foods, medications, or other causes face an increased risk. Initiate OMLYCLO only in a healthcare setting with anaphylaxis management capabilities. Patients should be monitored for an appropriate period post-administration, informed of signs and symptoms of anaphylaxis, and instructed to seek immediate medical care if they occur. Malignancy. Malignancies have been observed in clinical studies, with various cancer types reported. The long-term risk, especially in high-risk groups, is unknown. Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to alleviate asthma exacerbations acutely. Do not use OMLYCLO to treat acute bronchospasm or status asthmaticus. Corticosteroid Reduction. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of OMLYCLO therapy for asthma or CRSwNP. Eosinophilic Conditions. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids. Fever, Arthralgia, and Rash. Stop OMLYCLO if a patient develops a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy. Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection while on OMLYCLO therapy. Laboratory Tests. Administration of omalizumab products increases serum total IgE due to drug:IgE complexes. Do not use serum total IgE levels within one year of discontinuation of omalizumab products to reassess dosing regimen, as they may not reflect steady-state free IgE. Potential Medication Error Related to Emergency Treatment of Anaphylaxis. OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis. Instruct patients that OMLYCLO is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens. Most Common Adverse Reactions Asthma: In patients ≥12 years, reported in ≥1%: arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In pediatric patients (6 to <12 years), reported in ≥3%: nasopharyngitis, headache, pyrexia, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. CRSwNP: In patients ≥3% of adults: headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness. IgE-Mediated Food Allergy: In ≥3% of patients: injection site reactions and pyrexia. CSU: In ≥2% of patients: nausea, nasopharyngitis, sinusitis, upper respiratory tract infections (viral and non-viral), arthralgia, headache, and cough. Asthma: In patients ≥12 years, reported in ≥1%: arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In pediatric patients (6 to <12 years), reported in ≥3%: nasopharyngitis, headache, pyrexia, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. CRSwNP: In patients ≥3% of adults: headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness. IgE-Mediated Food Allergy: In ≥3% of patients: injection site reactions and pyrexia. CSU: In ≥2% of patients: nausea, nasopharyngitis, sinusitis, upper respiratory tract infections (viral and non-viral), arthralgia, headache, and cough. For more information, see Full Prescribing Information. About Celltrion Celltrion 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 USA Celltrion 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, endocrinology and ophthalmology 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), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav), 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 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 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. Trademarks OMLYCLO® is a registered trademark of CELLTRION, Inc. XOLAIR® is a registered trademark of Novartis AG. References [1] OMLYCLO U.S. prescribing information (2025)

Celltrion, Inc. today announced that Health Canada has approved Eydenzelt®, a biosimilar referencing Eylea® (aflibercept 2mg), in both vial and pre-filled syringe format, for treatment of all indications approved for Eylea.1 Celltrion公司今天宣布，加拿大卫生部已批准Eydenzelt®，这是一种参照Eylea®（阿柏西普2mg）的生物类似药，提供瓶装和预填充注射器两种形式，用于治疗所有已获批的Eylea适应症。“Today’s approval lays a solid foundation for Celltrion’s expansion into the Canadian ophthalmology market and represents a significant milestone in diversifying the company’s portfolio,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “Building on this milestone, Celltrion will further strengthen its presence in Canada by leveraging its advanced manufacturing capabilities and R&D expertise to improve patient access to high-quality biosimilar treatments.”. “今天的批准为Celltrion进入加拿大眼科市场奠定了坚实的基础，也是公司拓展产品组合的重要里程碑，”Celltrion Healthcare Canada总经理Jungyong Shin表示。“基于这一里程碑，Celltrion将通过利用其先进的生产能力与研发专长，进一步加强在加拿大的影响力，并改善患者获得高质量生物类似药治疗的机会。”The Health Canada approval is based on totality of evidence including analytical, nonclinical, and clinical data. A global, randomized, double-masked, parallel-group, multicenter Phase III study evaluated the efficacy, safety, pharmacokinetics, and immunogenicity of Eydenzelt compared to Eylea in patients with approved indications. 加拿大卫生部的批准是基于包括分析、非临床和临床数据在内的全部证据。一项全球性、随机、双盲、平行组、多中心的III期研究评估了Eydenzelt与Eylea在获批适应症患者中的有效性、安全性、药代动力学和免疫原性。The 52-week trial included 348 patients with diabetic macular edema (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.2. 为期52周的试验包括348名糖尿病性黄斑水肿（DME）患者。主要终点是从基线开始至第8周测量的最佳矫正视力变化，比较Eydenzelt和Eylea。研究结果显示，Eydenzelt达到了预定义的等效标准，且疗效、安全性和免疫原性的次要终点也显示出与Eylea相似的趋势。Eydenzelt is Celltrion's first Health Canada-approved biologic product in ophthalmology. Eydenzelt was also approved by the European Commission (EC) and the U.S. Food and Drug Administration (FDA) in February and October 2025, respectively. 艾德恩泽特（Eydenzelt）是Celltrion公司首款获加拿大卫生部批准的眼科生物制品。艾德恩泽特还分别于2025年2月和2025年10月获得欧洲委员会（EC）和美国食品药品监督管理局（FDA）的批准。Notes to Editors: 编辑须知：About Eydenzelt® 关于Eydenzelt®Eydenzelt® 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 Canada Eydenzelt is approved for the treatment of all indications approved for Eylea.1 Eydenzelt® 是一种血管内皮生长因子（VEGF）抑制剂，参照Eylea®（阿柏西普）。Eydenzelt基于确证与Eylea治疗等效的全面数据获得批准。在加拿大，Eydenzelt被批准用于所有Eylea已批准的适应症。1About Celltrion Inc. 关于Celltrion公司Celltrion 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. Celltrion是一家领先的生物制药公司，专注于研究、开发、制造、营销和销售改善全球人民生活的创新疗法。Celltrion是生物类似药领域的先驱，推出了全球首个单克隆抗体生物类似药。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. 我们的全球医药产品组合涵盖了多个治疗领域，包括免疫学、肿瘤学、血液学、眼科学和内分泌学。除了生物仿制药产品外，我们还致力于通过创新药物推进研发管线，突破科学创新的界限，提供高质量的药物。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.. 有关更多信息，请访问我们的网站 www.celltrion.com/en-us，并通过我们的社交媒体（LinkedIn、Instagram、X 和 Facebook）获取最新消息和活动动态。About Celltrion Healthcare Canada Limited 关于Celltrion Healthcare加拿大有限公司Celltrion Healthcare Canada is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with Health Canada regulations. With the approval of Eydenzelt®, Celltrion now has ten products across eight biosimilars approved by Health Canada: Remdantry™/ Remsima® SC (infliximab), Yuflyma® (adalimumab), Vegzelma® (bevacizumab), SteQeyma® (ustekinumab), Omlyclo® (omalizumab), Stoboclo® / Osenvelt® (denosumab), Avtozma™ (tocilizumab) and Eydenzelt® (aflibercept 2mg). Celltrion Healthcare Canada 致力于提供创新且价格合理的药物，以促进患者获得先进疗法的机会。其产品在符合加拿大卫生部法规的最先进的哺乳动物细胞培养设施中制造。随着 Eydenzelt® 的获批，Celltrion 目前已有十种产品、八种生物类似药获得加拿大卫生部批准：Remdantry™/ Remsima® SC（英夫利昔单抗）、Yuflyma®（阿达木单抗）、Vegzelma®（贝伐珠单抗）、SteQeyma®（乌司奴单抗）、Omlyclo®（奥马珠单抗）、Stoboclo® / Osenvelt®（地诺单抗）、Avtozma™（托珠单抗）和 Eydenzelt®（阿柏西普 2mg）。For more information, please visit: https://www.celltrionhealthcare.ca. 欲了解更多信息，请访问：https://www.celltrionhealthcare.ca。Eydenzelt® is trademarks of Celltrion, Inc. and are used under license. Eydenzelt® 是 Celltrion, Inc. 的商标，经许可使用。Eylea® is registered trademarks of Bayer Inc. Eylea® 是拜耳公司的注册商标。Contacts 联系人Media Relations Contact 媒体关系联系人info_CA@celltrionhc.com info_CA@celltrionhc.comJoey.Brogno@celltrionhc.com 乔伊·布罗格诺@细胞连接医疗.comSource: businesswire.com 来源：businesswire.com