FDA Accepts Biogen’s Application for Actemra Biosimilar


The acceptance of Biogen’s application follows regulator’s acceptance of an application by Fresenius Kabi for another Actemra biosimilar.

The FDA has accepted for review the abbreviated biologics license application (aBLA) for BIIB800, a biosimilar referencing Genentech’s Actemra (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. Actemra is indicated for several indications, including moderate-to-severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis. In 2021, Roche’s U.S. sales of Actemra totaled $1.9 billion

The FDA filing is supported by phase 3 data from a comparative clinical trial demonstrating equivalent efficacy and a comparable safety and immunogenicity profile at week 24 to the reference product. The data were presented at the European Congress of Rheumatology on June 3, 2022. In the trial, 621 patients were randomized to receive either BIIB800, tocilizumab or tocilizumab followed by BIIB800. The estimated proportions of patients achieving an ACR20 response in the BIIB800 vs. the TCZ groups, respectively, were 69.89% vs. 67.94% at Week 24. ACR response is scored as a percentage improvement, comparing disease activity at two time points. ACR20 is ≥ 20% improvement. This is a measure developed by the American College of Rheumatology.

In September 2022, the marketing authorization application. for BIIB800 was accepted for review by the European Medicines Agency.

Biogen announced in April 2021 that it entered into a commercialization and license agreement with Bio-Thera Solutions to develop, manufacture and commercialize BIIB800. Biogen has exclusive regulatory, manufacturing and commercial rights to BIIB800 in all countries excluding China.

Related: FDA Accepts BLA for Biosimilar of Actemra

In August 2022, the FDA accepted Fresenius Kabi biologics license application (BLA) for a biosimilar of Actemra. Fresenius Kabi expects to receive FDA approval for its tocilizumab biosimilar in 2023 and is seeking approval for both intravenous and subcutaneous routes of administration.

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