Infliximab-dyyb (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 States The 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 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. 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. 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. The content above comes from the network. if any infringement, please contact us to modify.

- Celltrion confirms a KRW 294.9 billion supply agreement, which may expand to KRW 375.4 billion, subject to mutual agreement. - Consecutive CMO wins, including Eli Lilly, push cumulative order backlog beyond KRW 1 trillion, supporting future revenue growth. - Growing requests for CDMO partnerships and increasing production of Celltrion’s own products are driving the need for additional manufacturing capacity. INCHEON, South Korea – Celltrion announced today that it has signed a contract manufacturing (CMO) agreement with a global pharmaceutical company for the supply of drug substance. The counterparty remains undisclosed to ensure business confidentiality. Under the agreement, Celltrion will supply drug substance for three years from 2027 through 2029. The contract value is approximately KRW 294.9 billion and may expand to KRW 375.4 billion, subject to mutual agreement. Celltrion plans to complete production arrangements early to ensure stable delivery. Strong product quality leads to contracts and accelerates CDMO business growth Celltrion has consistently demonstrated high manufacturing quality, reliable supply capabilities, and efficient production operations in supplying biologics. The latest contract reflects strong recognition of Celltrion’s manufacturing quality and stable supply system that meets global standards. Celltrion’s global CMO business has been expanding rapidly since the company announced plans to strengthen the business last year. Earlier this year, Celltrion signed a KRW 678.7 billion[1] CMO contract with Eli Lilly, and with the addition of this agreement, the company’s cumulative CMO order backlog surpassed KRW 1 trillion within the first quarter of the year. These contracts with global pharmaceutical companies demonstrate growing recognition of Celltrion’s manufacturing technology and global supply capabilities in the market. Celltrion to review additional capacity expansion amid growing global CDMO demand As demand for CDMO partnerships from global pharmaceutical companies continues to grow, Celltrion is strengthening its global sales and project management capabilities through its subsidiary Celltrion BioSolutions to further streamline its CMO business operations. Celltrion differentiates its CMO business by offering technology-driven service models. One such service is its “formulation conversion CMO,” which provides partners with the company’s accumulated subcutaneous (SC) formulation technologies developed through products such as Remsima SC (marketed as Zymfentra in the United States) and Herzuma SC. Celltrion aims to move beyond traditional contract manufacturing to provide high-value CMO services that enhance partners’ product competitiveness, and will accelerate efforts to expand production capacity and infrastructure to support this strategy. In addition, as the global biopharmaceutical market continues to expand and pharmaceutical companies increasingly seek reliable manufacturing partners, interest in Celltrion’s manufacturing capabilities is also steadily growing. Celltrion currently has a total manufacturing capacity of 316,000 liters, including facilities in Songdo, Korea (Plants 1, 2 and 3 with a combined capacity of 250,000 liters) and its facility in Branchburg, New Jersey (66,000 liters). However, global sales of Celltrion’s own products, including Zymfentra, are expected to expand alongside the addition of new pipeline products. Consequently, a significant portion of existing production capacity is likely to be allocated to the manufacturing of Celltrion’s own products. At the same time, rapidly increasing CDMO demand from global pharmaceutical companies is further raising the need for additional manufacturing capacity in the mid to long term. Taking these factors into account, Celltrion is reviewing additional manufacturing facilities both domestically and overseas to ensure sufficient infrastructure and support growing global CDMO demand. “This large-scale CMO agreement once again shows that Celltrion’s manufacturing quality and supply capabilities are recognized in the global market,” a Celltrion official said. “Considering the need to expand manufacturing for our own products, along with the growth of the CDMO business and increasing global demand, we plan to actively pursue additional manufacturing capacity to support future growth.” [1] Initial base exchange rate (December 31, 2025): USD/KRW $1 = KRW 1,434.90.