Biogen claims first with FDA nod for biosimilar Actemra

Biogen says it is the first drugmaker in the US to get FDA approval for a biosimilar of Roche’s $3 billion blockbuster product Actemra.

The intravenous biosimilar of IL-6 inhibitor Actemra (tocilizumab) – called Tofidence (formerly BIIB800) – has been cleared for three of the indications for which Roche’s drug is used, including moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Roche first launched Actemra onto the US market in 2010 for rheumatoid arthritis, growing the product with a series of additional approvals in other indications, including COVID-19, which sparked a massive spike in sales of the drug to around $4 billion in 2021 right at the end of its patent life.

Last year, sales fell back to around $2.9 billion, with around $1.3 billion of that total coming from the US market.

Roche’s Genentech subsidiary filed a legal challenge in July against Biogen, seeking to block the entry of its Tofidence into the market and alleging infringement of various patents covering processes, methods of treatment, antibody subtypes, and compositions.

In a statement, Biogen said it is “currently evaluating the potential launch timeline for Tofidence in the US.”

The basic patents on Actemra are all expired, and Roche recently said it expected the first biosimilars to reach the market in both the US and Europe before the end of this year. Last month, Fresenius Kabi became the first drugmaker to get EU approval for a biosimilar of tocilizumab last month.

“The approval of Tofidence in the US marks another positive step towards helping more people with chronic autoimmune conditions gain access to leading therapies,” remarked Ian Henshaw, global head of Biogen’s biosimilars unit.

“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,” he added.

Biogen licensed Tofidence from China’s Bio-Thera Solutions in 2021 and has exclusive rights to market it in all countries excluding China, including Hong Kong and Macau, as well as Taiwan.

The US biotech – currently in the throes of a major restructuring drive under new chief executive Chris Viehbacher – is reported to be considering the future of its biosimilars division, with rumours swirling of a potential sale to longstanding partner Samsung Bioepis and a bid from Indian drugmaker Intas.