EU Approves Avtozma Biosimilar
Celltrion announced that the European Commission (EC) has granted marketing authorization for Avtozma (CT-P47), a biosimilar referencing RoActemra (tocilizumab). Avtozma has been approved for all indications of its reference product, including 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 further strengthens Celltrion’s growing immunology portfolio.
“Today’s approval of Avtozma, a biosimilar to RoActemra, marks a critical step in Celltrion’s mission to provide European healthcare systems with affordable, effective solutions for immunological disorders. By leveraging our integrated operations, we strengthen the stability of supply chains and enhance collaboration with European healthcare professionals,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “We are committed to delivering value-driven solutions tailored to the unique needs of the European market.”
The EC approval on Avtozma was supported by a comprehensive data package and totality of evidence, including the results from a phase III study demonstrating biosimilarity between Avtozma and the reference product. The primary endpoint was met in terms of mean change from baseline in Disease Activity Score (DAS) using 28 joints (DAS28)-ESR at Week 12, and the final results supported comparability in secondary efficacy, pharmacokinetics (PK), safety and immunogenicity results between Avtozma and RoActemra
About CT-P47 Phase III Clinical Trial; This was a Phase III, randomised, active-controlled, double-blind trial to compare the efficacy and safety of Avtozma (CT P47) and RoActemra (tocilizumab) in patients with moderate to severely active rheumatoid arthritis (RA). Therapeutic equivalence of CT - P47 and reference tocilizumab in treating RA was demonstrated and supported by comparable and sustained efficacy results up to Week 52. CT P47 was also well tolerated with a safety profile comparable to reference tocilizumab, and no notable safety issue was identified following the single transition from reference tocilizumab to CT P47 compared with maintenance groups up to Week 52.
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