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FDA Agrees to Review Biogen Tocilizumab Biosimilar Application


The FDA has accepted Biogen’s biologics license application for a tocilizumab biosimilar candidate (BIIB800) referencing Actemra for review.

The FDA has accepted Biogen’s biologics license application for a biosimilar candidate (BIIB800) referencing Actemra (tocilizumab) for review. If approved, the drug will be used to treat several conditions, including rheumatoid arthritis, idiopathic polyarthritis, idiopathic arthritis, and sclerosis-associated interstitial lung disease.

Tocilizumab is a monoclonal antibody that inhibits interleukin-6 receptor. The news comes after the European Medicines Agency accepted Biogen’s marketing authorization application for BIIB800 for review in September 2022.

“The FDA filing is supported by phase 3 data from a comparative clinical trial demonstrating equivalent efficacy and a comparable safety and immunogenicity profile to the reference product…. We look forward to working with regulators to bring this potential treatment option for people with immune mediated inflammatory diseases,” wrote Ian Henshaw, head of global biosimilars at Biogen, in a statement.

The application includes positive data from a multicenter, multinational, randomized, double-blind, parallel-group, active-control phase 3 study assessing the safety and efficacy profiles of BIIB800 up to week 24. The data was presented at the European Congress of Rheumatology in June 2022. The trial included 621 patients with moderate-to-severe rheumatoid arthritis who have has an “inadequate response to methotrexate.”

Results from the study confirmed the safety, efficacy, pharmacokinetic, and immunogenicity profiles of the biosimilar compared with the reference product. The 1-year results from the study were presented at the American College of Rheumatology in November 2022.

In April 2022, Biogen announced that it would join forces with Bio-Thera Solutions as part of a commercialization and licensing agreement for the development, manufacturing, and commercialization of BIIB800. Biogen will have exclusive regulatory, manufacturing, and commercial rights to the tocilizumab candidate in all countries except China, which includes Hong Kong, Macau, and Taiwan.

In addition to BIIB800, Biogen has 2 other biosimilars: a ranibizumab (Byooviz) referencing Lucentis and an aflibercept candidate (SB15) referencing Eylea. Byooviz and SB15 will be used to treat retinal disorders, such as age-related macular degeneration and macular edema and are being developed as part of a deal with Samsung Bioepis.

Byooviz was approved in the United States, the European Union, and Canada as the first ranibizumab biosimilar and the first ophthalmology biosimilar. SB15 is currently being evaluated in a phase 3 study.

Samsung Bioepis and Biogen share the rights to Imraldi, a biosimilar referencing Humira (adalimumab). Data from a phase 1 study and a real-world study showing the clinical outcomes of Imraldi were presented at the European Congress of Rheumatology’s annual 2022 meeting.

Biogen has also entered a commercialization agreement with Xbrane Biopharma for Xcimzane, a biosimilar referencing Cimzia (certolizumab pegol) that would be used to treat rheumatoid arthritis, psoriasis, and other rheumatologic conditions.

In early 2022, Biogen announced that it would sell its 50% ownership stake in Samsung Bioepis, Samsung Biologics biosimilars division, which could be worth up to $2.3 billion.

In addition to Biogen, Fresenius Kabi, Gedeon Richter, and Enzene Biosciences with Hertero are developing tocilizumab biosimilars.

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