EC Grants Marketing Authorization to Celltrion Biosimilar for Arthritis Treatment

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 recommended Avtozma among five other biosimilars and 17 drugs overall for market authorization, saying at the time that other treatments for which tocilizumab has shown efficacy include chimeric antigen T-cell (CAR-T cell), induced severe or life-threatening cytokine release syndrome, and COVID-19 (2).

Previously, Celltrion had been identified in a report released at CPHI Barcelona in 2023 as one of two contract manufacturing organizations (CMOs), along with Fujifilm Diosynth, making substantial capacity investments that were putting them in position to displace two Big Pharma companies—namely, Novartis and Sanofi—on a top 10 list of companies in which the primary concentration of in-house cell culture capacity can be found (3). That capacity, at 54% as of 2023, is expected to rise to 57% by 2027, paralleling a forecasted growth in biologics demand of 11.5% per year.

Also in 2023, a partnership between Celltrion and fellow South Korean company Genuv was announced for the purpose of discovering and developing novel therapeutic antibodies (4).

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, including Vegzelma (CE-P16), a biosimilar to bevacizumab referencing Genentech’s Avastin, for the treatment of patients with metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer, which was announced in August 2022 (5). Another Celltrion treatment for COVID-19, meanwhile, Regkirona (regdanvimab, CT-P59), was approved by EC in November 2021 for use in adults who do not require supplemental oxygen and who are at increased risk of disease progression (6).

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. CPHI Barcelona: CMOs Expected to Account for 45% Available Bio Capacity in 2027. BioPharmInternational.com, Oct. 26, 2023.
4. Mirasol, F. Genuv and Celltrion Partner on Development of Novel Therapeutic Antibodies. BioPharmInternational.com, March 17, 2023.
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.