
EC Grants Marketing Authorization to Celltrion Biosimilar for Arthritis Treatment
Avtozma references Roche’s tocilizumab offering and has also shown promise as a treatment for CAR-T cell-induced cytokine release syndrome as well as COVID-19.
Celltrion, of Incheon, South Korea, announced on Feb. 24, 2025 that the European Commission (EC) granted marketing authorization for the company’s Avtozma (CT-P47), a biosimilar referencing Roche’s RoActemra (tocilizumab), for all indications (1). These include the treatment of moderate to severely active rheumatoid arthritis, both active systemic and polyarticular juvenile idiopathic arthritis, and giant cell arteritis, according to a Celltrion press release.
At its December 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use
Previously, Celltrion had been identified
Also in 2023, a partnership
In its February 24 press release, Celltrion said the approval of Avtozma would further strengthen the company’s immunology portfolio (1).
“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,” Taehun Ha, senior vice president and Head of Europe at Celltrion, said in the release. “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.”
EC’s decision on Avtozma—which Celltrion said was also approved by FDA in January 2025—was supported by data including results from a Phase III trial demonstrating the product’s biosimilarity to its reference product (1). Comparability between the Roche drug and the Celltrion candidate was confirmed in the areas of secondary efficiency, pharmacokinetics, immunogenicity results, and safety.
The treatment is Celltrion’s 12th biosimilar approved by EC,
References
1. Celltrion. Celltrion Receives EC Approval for Avtozma (CT-P47), a Biosimilar to RoActemra (tocilizumab). Press Release. Feb. 24, 2025.
2. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 9–12 December 2024. Press Release. Dec. 13, 2024.
3. Husni, D. G.
4. Mirasol, F.
5. Celltrion. European Commission Approves Celltrion Healthcare’s Vegzelma (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer. Aug. 19, 2022.
6. Celltrion. Celltrion’s Monoclonal Antibody Treatment regdanvimab, Approved by the European Commission for the Treatment of COVID-19. Press Release. Nov. 14, 2021.
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