FDA Approves Biogen’s Biosimilar, Challenging Roche’s Actemra Dominance in the Market

Biogen, Roche, Actemra, biosimilars, FDA approval, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, tofidence

Biogen has achieved a remarkable milestone while contemplating the future of its biosimilars division. The company proudly announced that its version of Roche’s autoimmune drug Actemra has received FDA approval, marking a groundbreaking achievement in the industry. Biogen’s biosimilar, set to be marketed as Tofidence (also known as tocilizumab-bavi), has been granted approval for the treatment of severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, as revealed in a statement by Biogen.

However, it’s important to note that Tofidence’s range of applications is not as extensive as Actemra’s. Roche’s Actemra holds FDA approvals for treating systemic sclerosis-associated interstitial lung disease, giant cell arteritis, and hospitalized COVID-19 patients, in addition to the conditions mentioned earlier.

Given that Roche’s Actemra garnered a substantial 2.7 billion Swiss francs (approximately $3 billion) in revenue last year, it remains a prime target for biosimilar developers. The drug saw increased demand during the COVID-19 pandemic but experienced a 22% sales decline in 2022 as the global health situation improved.

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“The approval of tofidence in the US marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies. 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.”

– Ian Henshaw, Global Head of Biosimilars at Biogen

The exact launch date for Biogen’s biosimilar, Tofidence, remains uncertain, as the company is currently evaluating the potential timeline for its release.

In its 2022 annual finance report, Roche disclosed that its primary patents for Actemra have expired in the United States and Europe. Roche anticipates that the first biosimilars to Actemra could enter the market in the second half of 2023. 

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This development coincides with Biogen’s ongoing deliberations regarding the strategic direction of its biosimilar division. Earlier rumors suggested that Biogen’s long-standing partner, Samsung Bioepis, was considering the acquisition of this unit, although no such deal has materialized.

In terms of financial performance, Biogen’s biosimilar franchise generated $751 million in revenue in 2022, reflecting a 10% decline compared to 2021. In the first half of the year, the division contributed $387 million to Biogen’s overall revenue.

It’s worth noting that Biogen secured the Actemra biosimilar through a licensing arrangement with Bio-Thera Solutions, the drug’s developer, granting Biogen worldwide rights for distribution, excluding China.

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