Celltrion has secured marketing authorisation from the European Commission (EC) for Avtozma (CT-P47), a biosimilar to Chugai Pharmaceutical’s RoActemra (tocilizumab).
The approval allows Avtozma to be used for the same range of conditions as RoActemra: moderate to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, giant cell arteritis and active systemic juvenile idiopathic arthritis. These are significant additions to Celltrion’s immunology offerings.
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The EC’s decision was underpinned by a data set and evidence totality, which included findings from a Phase III trial.
The study confirmed Avtozma’s biosimilarity to its reference product, achieving its primary endpoint with the mean change from baseline in Disease Activity Score (DAS28)-ESR at week 12.
It is the 12th biosimilar from the company to receive EC approval.
Celltrion Europe head and senior vice-president Taehun Ha stated: “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.”
A recombinant humanised monoclonal antibody, Avtozma, which contains tocilizumab, works as an interleukin 6 receptor antagonist.
The CT-P47 Phase III randomised, double-blind, active-controlled trial compared the efficacy and safety of the antibody and the reference in subjects with moderate to severely active RA.
Findings demonstrated therapeutic equivalence between CT-P47 and the reference tocilizumab, with comparable and sustained efficacy up to week 52.
CT-P47 was tolerated well, with a safety profile similar to that of the reference tocilizumab. No significant safety concerns were noted following a single transition from RoActemra to CT-P47 up to week 52.
In August 2024, the EC approved the company’s SteQeyma (CT-P43), a Stelara (ustekinumab) biosimilar for the treatment of chronic inflammatory conditions.
