Celltrion

AVTOZMA® (tocilizumab-anoh) is among the first wave of tocilizumab biosimilars with both intravenous (IV) and subcutaneous (SC) formulations approved and commercially available in the United StatesThe launch of AVTOZMA SC further diversifies Celltrion's immunology portfolio beyond TNF-alpha and IL-12/23 inhibitors providing a broader range of treatment solutions for immune-mediated inflammatory diseases INCHEON, South Korea, March 16, 2026 - Celltrion, Inc. today announced that AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation is now commercially available to patients in the United States. With this launch, Celltrion's AVTOZMA becomes one of the first tocilizumab biosimilars to have both an intravenous (IV) and a SC formulation approved by the U.S. Food and Drug Administration (FDA) and available on the U.S. market. "The introduction of AVTOZMA SC is a pivotal moment for Celltrion, underscoring our dedication to delivering effective, accessible and user-friendly therapies for patients with chronic inflammatory diseases," said Thomas Nusbickel, Chief Commercial Officer of Celltrion USA. "By offering both IV and SC formulations, we aim to provide patients and healthcare professionals with greater flexibility in treatment decisions, while continuing to broaden our immunology portfolio with therapies that address diverse inflammatory pathways." The SC formulation of AVTOZMA is indicated for the treatment of rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA). AVTOZMA SC is available in a 162 mg/0.9 mL solution for injection in a single-dose prefilled syringe or a single-dose prefilled autoinjector, allowing patients the flexibility and convenience of administering their treatment at home. [1] Celltrion provides support to U.S. patients prescribed AVTOZMA through its patient support program, Celltrion CONNECT™. Celltrion CONNECT™ offers tailored support to its patients and caregivers with a full range of services including injection training, reimbursement assistance and educational resources to patients and healthcare professionals. 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) IV 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). AVTOZMA® (tocilizumab-anoh) SC 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. 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 FullPrescribing 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, 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 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. 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. Trademarks AVTOZMA® 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)For further information please contact: Brendi Bluittbbluitt@jpa.com  +1 202-545-7722SOURCE Celltrion

- The FDA’s move to streamline PK testing and expand the use of non-U.S.-licensed comparator products is expected to reduce total clinical development costs by up to 25%.- Leveraging its internalized capabilities, Celltrion plans to expand its portfolio to include products targeting small and mid-sized markets, further strengthening economies of scale.- Celltrion plans to expand its biosimilar portfolio to 41 products by 2038, with the number of products under development expected to increase rapidly.- With capabilities spanning development, manufacturing and direct sales, Celltrion is well positioned to benefit from the regulatory changes. INCHEON, South Korea – Celltrion announced today that it will immediately incorporate newly announced global regulatory updates aimed at streamlining biosimilar development into its ongoing pipeline programs, with the goal of significantly reducing development costs and timelines. The company expects that the latest policy changes, combined with its expanding multi-product portfolio, will serve as a catalyst for achieving unprecedented economies of scale across its biosimilar business.The U.S. Food and Drug Administration (FDA) recently announced the fourth revision of the “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act,” aimed at streamlining the biosimilar development process. The revised draft guidance recommends streamlining clinical pharmacokinetic (PK) testing typically conducted during Phase 1 trials when scientifically justified. One of the most notable revisions involves the relaxation of comparator product requirements. Previously, biosimilar developers seeking approval in the United States were required to conduct direct PK comparison studies using a U.S.-licensed reference product. Under the updated guidance, however, comparative clinical data generated using a comparator product approved outside the United States may also be accepted to support a demonstration of biosimilarity. This change is expected to significantly reduce development costs, particularly in the immuno-oncology field where reference biologics are extremely expensive. Celltrion maintains strong competitiveness in this area with multiple products currently under development. The company therefore expects this measure alone could reduce overall clinical development costs by up to 25%. When combined with the FDA’s draft guidance issued in October last year aimed at reducing or waiving certain Phase 3 clinical studies, the overall cost-saving effect across the development process is expected to increase further. Although the revised guidance remains in draft form, Celltrion believes it reflects the FDA’s latest perspective, and plans to immediately apply the updated regulatory approach to its ongoing development programs to significantly shorten development timelines and reduce costs. Even prior to the regulatory changes, Celltrion has maintained industry-leading cost competitiveness through its integrated capabilities spanning development, manufacturing and direct sales. With a direct sales network already established across most key markets and additional savings expected from reduced clinical and comparator product costs, this cost advantage is expected to strengthen further. Celltrion also views the regulatory streamlining not merely as a cost-reducing measure, but as a strategic lever to achieve larger economies of scale across its entire product portfolio. By reinvesting resources saved through streamlined clinical requirements into additional pipeline development, the company expects to accelerate the expansion of its mid- to long-term product portfolio, including products targeting small and mid-sized markets that were previously difficult to pursue due to high clinical development costs. Streamlined regulatory requirements for clinical data and approval procedures are elevating the importance of expertise in antibody analytics, comparability assessment and process development, thereby favorably positioning companies like Celltrion who possess robust early-stage development capabilities. Beyond the 11 biosimilar products currently marketed globally, Celltrion plans to expand its portfolio to 41 products by 2038. Through this expansion, the company expects to target a global market projected to exceed KRW 400 trillion, more than four times larger than the KRW 85 trillion addressable market recorded last year. Celltrion believes that the recent global trend toward regulatory streamlining could support a further expansion of its product development plans. Key disclosed pipeline programs include CT-P53 (Ocrevus biosimilar), CT-P55 (Cosentyx biosimilar), CT-P52 (Taltz biosimilar) in autoimmune diseases, as well as CT-P51 (Keytruda biosimilar) and CT-P44 (Darzalex biosimilar) in oncology. In addition, more than 20 additional pipeline programs remain undisclosed. Notably, Celltrion recently reduced Phase 3 clinical trial enrollment for CT-P55 from 375 patients to 153, reflecting the impact of regulatory streamlining and suggesting the potential for faster development timelines. “The global trend toward regulatory streamlining presents a significant opportunity for Celltrion, which possesses strong early-stage development capabilities, large-scale manufacturing capacity and a global direct sales network,” a Celltrion official said. “By reinvesting the cost savings to further expand our pipeline, we aim to achieve greater economies of scale and strengthen our cost competitiveness as we continue advancing toward becoming a leading global biopharmaceutical company.”

- Early performance demonstrated with national tender wins in Norway and Denmark… Secured 35% share of the IV market in the Netherlands- The world’s first and only infliximab liquid formulation… Patent registrations completed across most European countries including the EU5- Continued field-friendly marketing activities through formulation innovation reflecting clinical needs… Enhancing brand value- The world’s first and only full infliximab portfolio of IV and SC formulations… “Will continue innovation in biosimilar products” [March 11, 2026, KST] Celltrion today announced the European launch of the liquid formulation of Remsima (infliximab), strengthening its leadership in the infliximab market. The infliximab liquid formulation is uniquely held by Celltrion globally and is supported by registered patents. As a newly introduced formulation reflecting clinical needs, it is expected to further reinforce Remsima’s influence through enhanced product competitiveness and expanded market impact. Celltrion’s Nordic affiliate achieved early success by securing contracts with the Remsima intravenous (IV) liquid formulation in infliximab national tenders held in Denmark and Norway. Following the European approval of the Remsima IV liquid formulation in November last year, the local affiliate had prepared in advance to ensure product distribution through key national tenders. As a result, sales in Norway began immediately after the tender award, with supply planned through January 2028. Through this, the product is expected to secure approximately 35% share of the infliximab IV market in Norway. The Remsima liquid formulation expands treatment options by reflecting clinical needs, alongside the existing Remsima IV (100 mg lyophilized formulation) and Remsima SC. In European clinical settings, there has been continuous demand for a multi-dose liquid formulation that enables more efficient storage and management while reducing the complexity of the preparation process. Reflecting these needs, Celltrion has introduced the Remsima 350 mg liquid formulation, while continuing to strengthen field-focused sales and marketing activities. With the field-friendly Remsima liquid formulation, healthcare institutions are expected to benefit from administrative and cost efficiencies, further strengthening the competitiveness of the Remsima portfolio. Compared with the lyophilized formulation, the liquid formulation can reduce preparation time by approximately 50%, while lowering labor and consumable costs by around 20% during drug preparation. In addition, storage space and related storage costs can be reduced by up to 70%, generating strong interest across Europe from the early stage of launch. The recent national tender award in Norway also reflects recognition of these advantages and is expected to serve as a new competitive strength for Remsima in Europe, where tender markets represent a significant portion of demand. Celltrion has also filed patents for the Remsima liquid formulation and has completed patent registrations in most European countries, including the EU5 markets such as the UK, Germany and France. As Remsima is the only infliximab product available in a liquid formulation, its differentiated competitiveness is expected to further strengthen its influence in the infliximab market. Following the development and commercialization of the world’s first infliximab SC formulation, Celltrion has now secured the IV liquid formulation, becoming the only company globally to establish a full portfolio of infliximab IV (lyophilized and liquid) and SC formulations. Based on this, the company aims to further strengthen brand trust in Remsima in the infliximab market, expand prescriptions across both Remsima IV and SC, and enhance profitability. In addition, Celltrion plans to continue product innovation reflecting clinical needs while reinforcing its differentiated corporate image with unique competitiveness in the biosimilar market. Starting with the Nordic region, Celltrion plans to expand the launch of the Remsima liquid formulation across Europe this year, including France, the Netherlands and the Czech Republic, further strengthening its leadership in the infliximab market. According to pharmaceutical market research firm IQVIA, the Remsima portfolio (IV and SC) maintained the No.1 position in infliximab prescriptions in Europe with a 68% market share as of Q3 last year. Based on the strengthened Remsima portfolio with a full formulation lineup, Celltrion plans to continue strengthening its market position while addressing diverse clinical needs. “As trust in Celltrion continues to build in the European biosimilar market, the Remsima liquid formulation reflects clinical needs and has demonstrated its competitiveness by securing tender wins immediately after launch," said Seung-doo Baek, Head of Celltrion’s Nordic affiliate. "Going forward, we will continue field-focused sales and marketing activities to provide better treatment options for patients and healthcare professionals in Europe while further expanding prescriptions.”