FDA Approves New Biosimilar for Adult & Pediatric Arthritis

On Sept. 29, the U.S. Food & Drug Administration (FDA) approved Tofidence (tocilizumab-bavi), a biosimilar monoclonal antibody referencing Actemra (tocilizumab). This biosimilar treatment was approved as an intravenous (IV) infusion for the treatment of moderate to severe active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA) and systemic juvenile idiopathic arthritis (sJIA). The U.S. launch timeline is currently being evaluated.¹

This agent is the first biosimilar of tocilizumab to garner FDA approval, as well as the first biosimilar FDA approved to treat JIA.² Actemra (tocilizumab), the reference product manufactured by Roche, was initially FDA approved on Jan 8, 2010, and RoActemra (tocilizumab) was initially approved by the European Medicines Agency on Jan. 15, 2009.^3,4

Background

This FDA approval is based on a thorough analytical review of clinical and non-clinical data submitted to the FDA in September 2022. The complete review included scientific evidence demonstrating that tocilizumab-bavi is highly similar to tocilizumab and that no clinically meaningful differences have been found between the two products. The evidence included comparisons of the two products on an analytical level, using extensive physicochemical tests and biological assays.

Comparative clinical data supporting the approval of tocilizumab-bavi included a pharmacokinetic study in healthy subjects who confirmed similar drug exposure following IV administration and a study in patients with rheumatoid arthritis (RA) who were not well controlled with methotrexate. Tocilizumab-bavi demonstrated similarity in efficacy, safety and immunogenicity end points.

Europe: In late July, the European Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the marketing authorization for the biosimilar Tyenne (tocilizumab) to treat patients with RA, active systemic JIA, JIA, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome and COVID-19. Tyenne is now available as 20 mg/mL IV infusion and as a 162 mg/mL solution for subcutaneous injection in a prefilled syringe.^5,6

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis [news release]. U.S. Food & Drug Administration. 2023 Sep 29.
2. FDA approves Biogen’s Tofidence (tocilizumab-bavi), a biosimilar referencing Actemra [news release]. Biogen. 2023 Sep 29.
3. Biologic license application approval letter: Actemra (tocilizumab). U.S. Food & Drug Administration. 2010 Jan 8.
4. Medicines: RoActemra—tocilizumab. European Medicines Agency. 2023 Apr 4.
5. EMA recommends approval of first aflibercept and tocilizumab biosimilars [news release]. Generics and Biosimilars Initiative. 2023 Aug 11.
6. Committee for Medicinal Products for Human Use (CHMP): 17–20 July 2023. E.U. European Medicines Agency. 2023.