Roche, Biogen quickly settle patent lawsuit over biosimilar of arthritis med Actemra

That didn’t take long. Roche has already settled a patent infringement lawsuit that it filed against Biogen in July.

The case surrounded Biogen’s biosimilar version of Roche’s blockbuster rheumatoid arthritis therapy Actemra. The settlement was unveiled in a filing at the U.S. District Court in Massachusetts on Monday.

The copycat, with the brand name Tofidence, last month became the first Actemra biosimilar to gain an FDA nod. At that time, Biogen said it was evaluating the potential launch timeline for the drug in the U.S.

The exact terms of the settlement weren’t made public. A Biogen spokesperson declined to comment beyond the court filing, adding that the company is still evaluating its launch timeline. Genentech didn’t immediately respond to a Fierce Pharma’s request for comment.

In other biosimilar patent settlements, the two sides have typically agreed on launch dates for the copycats in question.

For example, as part of a settlement Johnson & Johnson reached in June, the New Jersey pharma granted Alvotech and Teva a license to launch their proposed biosimilar to the blockbuster autoimmune therapy Stelara in the U.S. no later than Feb. 21, 2025.

For its part, Biogen in-licensed Tofidence from Bio-Thera Solutions in 2021 by paying the Chinese company $30 million upfront. The drug was approved in China in January.

With the lawsuit, Roche and its subsidiaries Genentech and Chugai claimed Biogen and Bio-Thera stepped on several Actemra patents, including methods of treating rheumatoid arthritis and its method of inhibiting the IL-6 receptor.

Roche also claimed that Biogen failed to provide detailed information when seeking approval for Tofidence.

Tofidence is targeting a big autoimmune market. Without contribution from the treatment of COVID-19, Actemra brought in 1.9 billion Swiss francs ($2.1 billion) in sales in the first nine months of 2023.

More clarity on Tofidence’s launch timeline could come next month, when Biogen provides its third-quarter financial results on Nov. 8. The Massachusetts biotech is currently undergoing a strategic review of its entire biosimilar franchise as part of a bigger, ongoing restructuring.

The company has already sold its stake in the joint venture Samsung Bioepis to its former partner Samsung Biologics. In August, reports emerged that Samsung Bioepis was in talks with Biogen to acquire the latter’s remaining biosimilar business.