The First Biosimilar for Actemra® is Approved by FDA

Partners Biogen and Bio-Thera announced on September 29 that they received US approval for Tofidence™ (tocilizumab-bavi), the first biosimilar for the interleukin-6 drug category. The drug is approved for the same indications as the reference product Actemra: treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Biogen biotechnology headquarters seen in Cambridge, Massachusetts, on Oct. 5, 2018. (Ruby Wallau for STAT)

Formerly known as BAT1806 or BIIB800, Tofidence may face additional competition from Fresenius Kabi, though the approval for its investigational product MSB11456 seems delayed (the FDA accepted this 351(k) application in August 2022).

“The approval of Tofidence in the US marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” stated Ian Henshaw, Global Head of Biosimilars at Biogen, in the company’s press release. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”

No launch date has been announced for Tofidence. According to the announcement, “Biogen is currently evaluating the potential launch timeline for Tofidence in the US.”

The data package evaluated by the FDA included phase 1 and phase 3 double-blind studies (the latter in patients with rheumatoid arthritis) comparing Tofidence with the reference product. No significant differences were seen in pharmacokinetic or clinical efficacy trials between the agents.

Actemra’s US sales for Roche were approximately $2 billion in 2022.

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