Roche has swiftly resolved a patent infringement lawsuit it initiated against Biogen in July. The legal dispute centered around Biogen’s biosimilar version of Roche’s highly successful rheumatoid arthritis treatment, Actemra. The details of the settlement were disclosed in a filing at the US District Court in Massachusetts earlier this week.
Biogen’s biosimilar product, marketed as Tofidence, recently secured FDA approval, becoming the first biosimilar to Actemra to achieve this milestone. Biogen announced that it is currently assessing the potential launch schedule for Tofidence in the United States. Unfortunately, the precise terms of the settlement remain undisclosed, and both Biogen and Genentech, Roche’s subsidiary, have refrained from commenting further at this time.
Historically, biosimilar patent settlements have frequently included agreements on launch dates for the respective biosimilars. For instance, in June, Johnson & Johnson reached a settlement that granted Alvotech and Teva the authorization to introduce their proposed biosimilar of the blockbuster autoimmune therapy Stelara in the US no later than February 21, 2025.
Also Read: FDA Approves Biogen’s Biosimilar, Challenging Roche’s Actemra Dominance In The Market
Biogen initially acquired Tofidence from Bio-Thera Solutions in 2021, paying $30 million upfront. The drug obtained approval in China in January, further expanding its market presence. With Actemra contributing significantly to the autoimmune treatment market, generating 1.9 billion Swiss francs (approximately $2.1 billion) in sales in the first nine months of 2023, Tofidence is strategically positioned to capture a substantial share of this market.
Additional insights into Tofidence’s launch timeline may be provided in November when Biogen discloses its third-quarter financial results on the 8th. The Massachusetts-based biotech firm is currently undergoing a comprehensive strategic review of its biosimilar portfolio as part of a broader restructuring initiative. In August, reports indicated that Samsung Bioepis, Biogen’s former partner, was in negotiations to acquire Biogen’s remaining biosimilar business, following Biogen’s sale of its stake in the joint venture Samsung Bioepis.
