Celltrion Receives EC Approval for Avtozma ®, Biosimilar of RoActemra ®
Celltrion has announced that the European Commission (EC) has granted marketing authorization for Avtozma® (CT-P47), a biosimilar to RoActemra® (tocilizumab). This approval encompasses all the indications of its reference product, including moderately to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (SJIA), polyarticular juvenile idiopathic arthritis (JIA), and giant cell arteritis (GCA). The approval strengthens Celltrion’s expanding portfolio of immunological products and enhances its presence in the European market.
The approval of Avtozma® marks a significant milestone in Celltrion’s ongoing mission to provide affordable and effective solutions for immune-mediated disorders. “Today’s approval of Avtozma®, a biosimilar of RoActemra®, is a key step for Celltrion in providing European healthcare systems with high-quality, accessible treatment options for patients with immune-mediated conditions,” said Taehun Ha, Senior Vice President and Head of Europe for Celltrion. “By leveraging our integrated operations, we are strengthening supply chain stability and increasing collaboration with healthcare professionals across Europe to meet the needs of the market.”
The EC approved Avtozma® based on a comprehensive data package, including results from a Phase III clinical trial that demonstrated the biosimilarity between Avtozma® and the reference product, RoActemra®. The trial achieved its primary endpoint by demonstrating a significant improvement in the Disease Activity Score (DAS28-ESR) after 12 weeks of treatment. In addition, the results supported the comparability of the two products in terms of efficacy, pharmacokinetics (PK), safety, and immunogenicity.
This approval marks Avtozma® as Celltrion’s twelfth biosimilar product to be approved by the EC. Other approved biosimilars include Remsima® (intravenous infliximab), Remsima® SC (subcutaneous infliximab), Yuflyma® (adalimumab), SteQeyma® (ustekinumab), Truxima® (rituximab), Herzuma® (trastuzumab), Vegzelma® (bevacizumab), Omlyclo® (omalizumab), Eydenzelt® (aflibercept), Stoboclo®, and Osenvelt® (denosumab).
The CT-P47 Phase III Clinical Trial
The Phase III clinical trial that led to the approval of Avtozma® was a randomized, double-blind, actively controlled study designed to compare the efficacy and safety of Avtozma® (CT-P47) with RoActemra® (tocilizumab) in patients with moderately to severely active rheumatoid arthritis (RA). The study demonstrated therapeutic equivalence between the two products, with Avtozma® showing comparable and sustained efficacy through 52 weeks of treatment. Avtozma® was also well tolerated, with a safety profile similar to that of RoActemra®, and no significant safety concerns were identified after patients transitioned from the reference product to Avtozma®.
About Avtozma® (CT-P47, Biosimilar Tocilizumab)
Avtozma®, containing the active substance tocilizumab, is a recombinant humanized monoclonal antibody that works by acting as an interleukin-6 (IL-6) receptor antagonist. IL-6 plays a key role in the inflammatory process, and targeting its receptor is a well-established therapeutic approach for treating autoimmune diseases.
Based on the data from the Phase III clinical trial, which evaluated the efficacy, pharmacokinetics, safety, and immunogenicity of Avtozma® in comparison to the reference product, Avtozma® has been approved for all indications of RoActemra®. These include moderate to severe RA, active systemic juvenile idiopathic arthritis (SJIA), polyarticular juvenile idiopathic arthritis (JIA), and giant cell arteritis (GCA). In addition to the EC approval, the US Food and Drug Administration (FDA) granted approval for Avtozma® in January 2025.
About Celltrion
Celltrion is a leading global biopharmaceutical company focused on the research, development, manufacturing, and commercialization of innovative therapies. The company is a pioneer in the biosimilar field, having launched the world’s first monoclonal antibody biosimilar. Celltrion’s portfolio spans diverse therapeutic areas, including immunology, oncology, hematology, ophthalmology, and endocrinology. In addition to its biosimilar products, Celltrion is committed to advancing its pipeline of new treatments to push the boundaries of scientific innovation and deliver high-quality, effective medicines worldwide.
Celltrion’s expertise in biosimilars positions the company at the forefront of affordable, high-quality therapies that address a range of chronic and complex diseases. Through its continued commitment to research and development, Celltrion strives to meet the evolving needs of patients and healthcare systems globally.
