Celltrion

Celltrion will add Plants 4 and 5 at its Songdo HQ with a total capacity of 180,000 liters, while also undertaking a 75,000-liter expansion at its U.S. manufacturing site.Celltrion’s total DS production capacity will be expanded to 571,000 liters, with the goal of achieving 100% internalization of DS production by 2031 and further cost reductions.Through the establishment of sustainable manufacturing infrastructure, Celltrion aims to strengthen cost competitiveness and supply stability, and build a foundation for its CMO business.Celltrion is also expanding DP manufacturing facilities in Songdo and Yesan, which is expected to enable approximately 90% internalization of its global DP supply.Celltrion plans to proactively respond to the expanding product portfolio and global demand, while actively considering securing additional manufacturing capacity if necessary. INCHEON, South Korea – Celltrion announced today that it plans to secure additional manufacturing capacity through a large-scale expansion investment exceeding KRW 1 trillion at its Songdo headquarters to respond to rapidly increasing global demand for its biologics portfolio and further strengthen its global manufacturing competitiveness. The expansion investment will be implemented in phases from this year through 2030 and will focus on expanding manufacturing infrastructure across the Songdo campus in Korea, the company’s production base in the U.S., and domestic business sites. This investment goes beyond expanding manufacturing capacity and is intended to establish a long-term growth foundation to support the reliable production and supply of next-generation biosimilars and innovative drug candidates currently under development, while enabling the expansion of the company’s global contract manufacturing (CMO) business. KRW 1.2Tn investment in the Songdo campus to construct Plants 4 and 5 with a total capacity of 180,000 liters to support pipeline products and CMO demand Celltrion will invest KRW 1.2265 trillion to construct Plants 4 and 5 with a combined capacity of 180,000 liters at its Songdo campus in Incheon, where the company’s headquarters are located. The new facilities will incorporate advanced automation systems and smart factory technologies, which are expected to maximize production efficiency and operational flexibility. This will enable a wide range of production capabilities, from small-batch, multi-product production to large-scale manufacturing, allowing the company to respond more rapidly to the production needs of its next-generation biosimilars and novel drugs to be launched in the future as well as its current key products. The planned facility expansion is intended to support the rapidly growing production demand of the company’s follow-on pipeline while proactively responding to increasing CMO requests. Branchburg facility in the U.S. to be expanded by 75,000 liters… total DS production capacity to reach 570,000 liters globally To further strengthen its competitiveness in the United States, Celltrion has finalized the scope of expansion of the manufacturing facility in Branchburg, New Jersey. The planned expansion has been increased from the originally proposed 66,000 liters to 75,000 liters, bringing the facility’s total production capacity for drug substances (DS) from the current 66,000 liters to 141,000 liters. As demand for local biologics manufacturing in the United States continues to grow rapidly, the Branchburg facility is expected to play a key role in supporting Celltrion’s supply of its products in the U.S. and expanding its CMO business. Once the facility expansions in Korea and overseas are completed, Celltrion’s DS production capacity will increase significantly from the current 316,000 liters to 571,000 liters. Upon completion of the expansion, Celltrion expects to achieve 100% internalization of DS production while realizing significant additional cost savings. Company-wide DP manufacturing expansion in Songdo and Yesan, aiming to raise DP production internalization to 90% In addition to strengthening its DS manufacturing capabilities, Celltrion is making broad investments to enhance its global competitiveness in drug product (DP) manufacturing. The new DP plant currently under construction at the Songdo campus has reached over 70% completion and is expected to be finished within this year, with commercial operations scheduled to begin next year. The facility will serve as a DP-only production plant and will be capable of producing up to 6.5 million liquid vials annually. Together with the existing DP line at Plant 2, which has a maximum annual output of 4 million vials, Celltrion will secure total DP capacity of approximately 10.5 million vials per year in Songdo alone. In addition, Celltrion has also finalized the site for a new DP manufacturing facility in Yesan Industrial Complex, Chungcheongnam-do, and plans to begin design work within this year. Once the Yesan DP facility is completed and the planned expansion of pre-filled syringe (PFS) manufacturing facilities by Celltrion Pharm is carried out, the company expects to internalize approximately 90% of its global DP supply volume, enabling substantial cost savings compared with overseas DP contract manufacturing. Meanwhile, Celltrion is conducting thorough reviews of safety management systems across all ongoing construction projects and will prioritize safety as the top priority in all expansion projects, including Plants 4 and 5. Responding with agility to surging global demand… “Additional manufacturing expansion may be considered, if necessary.” Through sequential domestic and overseas expansion investments, Celltrion plans to fully implement its global two-track manufacturing strategy and maximize its market responsiveness to rapidly changing economic conditions. Domestic manufacturing facilities will enhance production internalization and improve cost efficiency, strengthening competitiveness in global tenders and driving revenue growth in markets outside the United States. For its part, the U.S. manufacturing site will serve as a local supply hub for Celltrion’s products and CMO production, thereby proactively mitigating potential trade risks such as tariffs while enhancing local profitability. “This investment will enable the company to respond swiftly to rapidly growing global demand for biologics while significantly improving profitability through strengthened cost competitiveness and supply stability,” a Celltrion official said. “By establishing a comprehensive manufacturing infrastructure encompassing both innovative drugs and biosimilars as two key growth pillars, along with our expanding CMO business, Celltrion will take another step forward toward becoming a global top-tier biopharmaceutical company.” Looking ahead, Celltrion plans to actively consider securing additional manufacturing facilities in line with global market conditions and the launch of its pipeline products if necessary.

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.”