Celltrion has received the European Commission (EC) marketing authorisation for Avtozma, a biosimilar to Roche’s arthritis drug RoActemra (tocilizumab).
RoActemra is a recombinant humanised monoclonal antibody designed to serve as an interleukin 6 (IL-6) receptor antagonist.
Avtozma has been approved for all indications of its reference product, RoActemra.
The indications include active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA).
The regulatory approval will further strengthen its growing immunology portfolio, said the South Korea-based biopharmaceutical company.
Celltrion senior vice president and Europe head Taehun Ha said: “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.
“We are committed to delivering value-driven solutions tailored to the unique needs of the European market.”
The EC approval was supported by results from a Phase 3 randomised, active-controlled, double-blind trial study, which proved biosimilarity between Avtozma and RoActemra.
The study compared the efficacy and safety of Avtozma and RoActemra in patients with moderate to severely active rheumatoid arthritis (RA).
It has met the primary endpoint of mean change from baseline in Disease Activity Score (DAS) using 28 joints (DAS28)-ESR at Week 12.
Also, the final results from the study supported comparability in secondary efficacy, pharmacokinetics (PK), safety and immunogenicity between Avtozma and RoActemra.
In the study, Avtozma showed a therapeutic equivalence with reference tocilizumab in treating RA, supported by comparable and sustained efficacy results up to Week 52.
The biosimilar was also well tolerated with a safety profile comparable to reference tocilizumab, and no safety issue was reported. Last month, Celltrion received the US Food and Drug Administration (FDA) approval for Avtozma in both an intravenous (IV) and subcutaneous (SC) formulation.
