Despite a second wind for Actemra courtesy of the COVID-19 pandemic, Roche has warned the interleukin-6 inhibitor’s blockbuster sales run is nearing its end. Still, the company isn’t letting its aging arthritis drug go down without a fight.
Roche and its subsidiaries Genentech and Chugai Pharmaceutical late last week mounted a lawsuit in Massachusetts over claims that Biogen’s proposed biosimilar to Actemra, BIIB800, violates multiple plaintiff-held patents.
Roche has accused Biogen of making several missteps in the “statutory patent dance” surrounding the biosimilar approval process in the U.S.
For one, it argues Biogen failed to provide enough information on how its copycat is manufactured. Roche also took issue with Biogen’s alleged cribbing of intellectual property pertaining to methods of treating rheumatoid arthritis, the indication for which Actemra won its original approval back in 2010. Moreover, the Swiss pharma contends that BIIB800’s method of inhibiting the IL-6 receptor is itself a violation of the company’s so-called ‘800 patent.
In return, Roche is requesting a jury trial and seeking both an injunction against the production and sale of Biogen’s copycat plus potential damages from any lost profits.
Roche confirmed in an emailed statement that it filed a complaint against Biogen. The company said it considers biosimilar competition “a normal part of a biologic treatment’s lifecycle” that has an “important role to play in supporting the financial...
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