Competition is heating up in a new drug category. Biogen announced today that the FDA has accepted its biosimilar application for BIIB800 (also known as BAT1806), a potential competitor to the reference product Actemra (tocilizumab). This is the second tocilizumab biosimilar sent for approval by the FDA. In August, Fresenius Kabi announced that it filed its own application for MSB11456.
An interleukin-6 receptor monoclonal antibody, Actemra is indicated for several autoimmune disorders, including rheumatoid arthritis, and juvenile idiopathic polyarthritis and arthritis. Biogen’s phase 3 clinical trial was conducted in patients with moderate- to severe rheumatoid arthritis, demonstrating equivalent clinical efficacy and safety outcomes with the reference product. The trial was completed in 2021, and results reported in June 2022 at the European Congress of Rheumatology.
Development of this biosimilar is the result of a partnership between Biogen and China-based Bio-Thera Solutions. This biosimilar is also under review by the European Medicines Agency.
Roche announced US revenues in 2021 of $1.9 billion on Actemra, and it is trying to maintain its share by moving patients to a subcutaneous formulation (Biogen’s biosimilar tests were conducted with an infusible form only). Fresenius Kabi’s testing was conducted with the subcutaneous formulation.
A portion of Roche’s revenue had been associated with its emergency use authorization for patients hospitalized with COVID-19 (for example, sales of the agent in third-quarter 2021 were 57% higher than sales in the third-quarter 2020). This raises the question of whether the FDA will also consider extrapolation to COVID-19 use in its decision, which is expected in the late fourth quarter of 2023.
Beyond Fresenius Kabi and Biogen, the only manufacturers that have publicly announced their intention to develop a tocilizumab biosimilar is Celltrion, which is completing a phase 1 study.
In Other Biosimilar News
Express Scripts joined OptumRx in announcing its intention to add multiple adalimumab biosimilars onto its preferred formulary next year. No information about timing or specific biosimilar inclusions is available at this time.
Viatris has begun a switching trial of its Hulio® adalimumab biosimilar, with an eye towards completion in October 2023. This trial is being conducted with the low-dose concentration of the product. This could mean a Q3-4 interchangeable designation for this formulation.