Celltrion Secures EC Approval for Avtozma® (CT-P47), a Biosimilar to RoActemra®
Celltrion has announced that the European Commission (EC) has granted marketing authorization for Avtozma® (CT-P47), a biosimilar referencing RoActemra® (tocilizumab). This approval marks a significant milestone for Celltrion, reinforcing its position as a leading player in the global biosimilar market. Avtozma® has been approved for all indications of its reference product, including the treatment of moderately to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (SJIA), polyarticular juvenile idiopathic arthritis (JPIA), and giant cell arteritis (GCA). The approval of Avtozma® further strengthens Celltrion’s growing immunology-focused portfolio and supports the company’s mission to expand access to high-quality, cost-effective biologics across Europe.
Strengthening Access to Affordable Immunological Therapies
“Today’s approval of Avtozma®, a biosimilar of RoActemra®, marks a key step in Celltrion’s mission to provide European healthcare systems with affordable and effective solutions for immune-mediated disorders,” said Taehun Ha, Senior Vice President and Head of Europe for Celltrion. “By leveraging our integrated operations, we are strengthening the stability of supply chains and enhancing collaboration with European healthcare professionals. We are committed to delivering quality solutions tailored to the specific needs of the European market.”
The European Commission’s approval was based on extensive analytical, preclinical, and clinical data that demonstrated the biosimilarity of Avtozma® to RoActemra® in terms of efficacy, safety, pharmacokinetics (PK), and immunogenicity. The approval process followed rigorous regulatory standards to ensure that the biosimilar meets the same quality, safety, and effectiveness criteria as its reference product.
Clinical Evidence Supporting Avtozma® Approval
The regulatory approval was supported by data from a Phase III clinical trial that confirmed Avtozma®’s equivalence to RoActemra®. The study, a randomized, actively controlled, double-blind trial, compared the efficacy and safety of Avtozma® with its reference product in patients with moderately to severely active rheumatoid arthritis (RA). The primary endpoint was met, demonstrating comparable improvements in Disease Activity Score (DAS) across 28 joints (DAS28-ESR) at Week 12. Additionally, the final results at Week 52 confirmed therapeutic equivalence in terms of efficacy, safety, and pharmacokinetics.
The findings from this clinical program provided robust evidence to support the approval of Avtozma® for all indications covered by RoActemra®, ensuring that patients across Europe have access to a high-quality alternative for managing immune-mediated diseases.
Expanding Celltrion’s Biosimilar Portfolio
With the approval of Avtozma®, Celltrion now has a total of twelve biosimilars approved in Europe. These include:
- Remsima® (intravenous infliximab)
- Remsima® SC (subcutaneous infliximab)
- Yuflyma® (adalimumab)
- SteQeyma® (ustekinumab)
- Truxima® (rituximab)
- Herzuma® (trastuzumab)
- Vegzelma® (bevacizumab)
- Omlyclo® (omalizumab)
- Eydenzelt® (aflibercept)
- Stoboclo® (denosumab)
- Osenvelt® (denosumab)
This diverse portfolio highlights Celltrion’s commitment to bringing high-quality biosimilar alternatives to market, increasing treatment accessibility, and reducing healthcare costs for patients and providers.
The Science Behind Avtozma®
Avtozma® contains the active substance tocilizumab, a recombinant humanized monoclonal antibody that acts as an interleukin-6 (IL-6) receptor antagonist. By blocking IL-6 signaling, tocilizumab helps to reduce inflammation and disease progression in autoimmune disorders such as rheumatoid arthritis and giant cell arteritis.
The extensive clinical data package submitted for regulatory review included pharmacokinetic, pharmacodynamic, immunogenicity, and safety data. The results demonstrated that Avtozma® exhibits no clinically meaningful differences from its reference product, ensuring that patients switching from RoActemra® to Avtozma® will experience the same therapeutic benefits.
Regulatory Approvals and Global Expansion
The European approval of Avtozma® follows a similar decision by the U.S. Food and Drug Administration (FDA), which granted marketing authorization for the biosimilar in January 2025. This approval underscores the growing confidence in Celltrion’s ability to develop and manufacture high-quality biosimilars that meet the stringent regulatory requirements of global health authorities.
Celltrion is actively working to expand the availability of Avtozma® beyond Europe and the U.S., with regulatory submissions underway in other key markets, including Canada, Australia, and Asia-Pacific regions.
Addressing the Growing Demand for Biosimilars
As healthcare systems worldwide continue to face increasing financial pressures, biosimilars like Avtozma® offer a cost-effective alternative to expensive biologic therapies. By offering biosimilars at a lower price point, Celltrion aims to improve treatment accessibility and affordability while maintaining the highest standards of quality and efficacy.
The European approval of Avtozma® aligns with the broader industry trend toward increased biosimilar adoption, driven by the need to lower drug costs without compromising on treatment effectiveness. With multiple autoimmune and inflammatory conditions requiring long-term biologic therapy, the introduction of biosimilars plays a critical role in ensuring sustainable healthcare solutions.
