Celltrion Gets EC Approval for Avtozma® (CT-P47), Biosimilar to RoActemra®
Celltrion announced today that it has received marketing authorization from the European Commission (EC) for Avtozma® (CT-P47), a biosimilar referencing the reference biologic RoActemra® (tocilizumab). This approval allows Avtozma® to be used for all indications of the original product, which include moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA). The approval bolsters Celltrion’s expanding immunology portfolio and enhances its ability to provide European healthcare systems with cost-effective treatments for immunological disorders.
Taehun Ha, Senior Vice President and Head of Europe at Celltrion, highlighted the significance of this approval, stating, “Today’s approval of Avtozma® marks a critical step in Celltrion’s mission to deliver affordable and effective solutions to European healthcare systems. By leveraging our integrated operations, we are not only ensuring stability in the supply chain but also strengthening collaboration with healthcare professionals across Europe. We remain committed to delivering value-driven solutions tailored to the needs of the European market.”
The approval of Avtozma® is based on comprehensive data, including results from a Phase III clinical trial that demonstrated biosimilarity between Avtozma® and RoActemra®. The trial results showed that the primary endpoint was met with a mean change from baseline in Disease Activity Score using 28 joints (DAS28)-ESR at Week 12. Moreover, secondary efficacy measures, pharmacokinetics (PK), safety, and immunogenicity were all comparable between Avtozma® and the reference product, confirming the therapeutic equivalence of the two.
This approval marks Celltrion’s twelfth biosimilar product granted authorization by the EC. The company’s extensive biosimilar portfolio includes products such as 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). This broad portfolio of biosimilars allows Celltrion to address a wide range of therapeutic areas and better meet the diverse needs of healthcare systems and patients worldwide.
CT-P47 Phase III Clinical Trial Results
The Phase III clinical trial evaluating Avtozma® (CT-P47) compared its efficacy and safety with RoActemra® (tocilizumab) in patients with moderate to severely active RA. The study demonstrated therapeutic equivalence between the two treatments, showing comparable and sustained efficacy up to Week 52. Furthermore, the safety profile of Avtozma® was similar to that of RoActemra®, with no significant safety concerns arising from the switch from RoActemra® to Avtozma® in the transition group. This further supports Avtozma® as a safe and effective alternative to the reference biologic.
The trial also highlighted the durability of the therapeutic effects, as well as the well-tolerated nature of Avtozma® over the course of the study. The results indicate that patients transitioning from the reference product to Avtozma® can expect comparable outcomes in terms of disease control and safety, providing a seamless treatment experience for patients with RA.
About Avtozma® (CT-P47)
Avtozma® is a recombinant humanized monoclonal antibody that targets the interleukin-6 (IL-6) receptor, playing a critical role in the inflammatory process of diseases such as RA, sJIA, pJIA, and GCA. This biosimilar product has been thoroughly tested in clinical trials, demonstrating its efficacy, pharmacokinetics, and safety profile as comparable to RoActemra®. Following the EC approval, Avtozma® is now authorized for use in all the same indications as the reference product, helping to address the unmet needs of patients suffering from these challenging inflammatory diseases.
In addition to its European approval, Avtozma® was also granted approval by the U.S. Food and Drug Administration (FDA) in January 2025, further expanding its availability to patients in the U.S. and Europe. This dual approval represents a significant milestone for Celltrion, positioning Avtozma® as an important treatment option in the global immunology market.
About Celltrion
Celltrion is a global biopharmaceutical company that is dedicated to the research, development, manufacturing, marketing, and sales of innovative therapeutics. Specializing in the biosimilar space, Celltrion made history by launching the world’s first monoclonal antibody biosimilar. The company’s comprehensive portfolio spans multiple therapeutic areas, including immunology, oncology, hematology, ophthalmology, and endocrinology. Beyond biosimilars, Celltrion is committed to advancing its pipeline of novel drugs, driving forward scientific innovation, and improving patient outcomes worldwide.
As a leader in the biosimilar industry, Celltrion is committed to making high-quality, affordable medicines accessible to patients across the globe. By continuously expanding its product offerings and advancing its research capabilities, Celltrion remains at the forefront of the biopharmaceutical industry, with a strong focus on meeting the evolving needs of healthcare systems and improving patient lives.
