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 sustainability of healthcare systems, while making headroom for innovation.”
Biogen, for its part, declined to comment on pending litigation.
Biogen announced the FDA’s acceptance of its Actemra biosimilar application in December. Meanwhile, the European Medicines Agency accepted Biogen’s marketing application overseas in September. The company is working in tandem with Bio-Thera solutions on the development, production and marketing of its Actemra copycat in all countries save for China.
In its 2022 annual report published earlier this year, Roche suggested (PDF) the first biosimilar versions of Actemra could arrive in Europe and the U.S. in the second half of 2023. Across the pond, Roche’s blockbuster antibody goes by the name RoActemra. As it stands, the med’s “basic, primary patents have expired in the U.S. and the E.U.,” Roche added.
Apart from Biogen, Fresenius Kabi and Celltrion each have late-stage Actemra copycats in the works. Fresenius currently seems to be leading the pack after it reported that the FDA had accepted its biosimilar application back in August 2022. Celltrion’s phase 3 copycat CT-P47 has also been submitted to the FDA, according to The Korea Herald.
Actemra has enjoyed a nice sales boost at the end of its patent exclusivity period thanks to its use in treating COVID-19. Early in the pandemic, officials in China recommended Roche’s drug for patients who developed an uncontrolled immune response to the coronavirus. And after being added to Chinese COVID-19 treatment guidelines in March 2020, Actemra nabbed an FDA emergency nod to treat certain severe COVID patients in June 2021, which evolved into a full FDA approval in 2022.
For all of 2022, Actemra brought home U.S. sales of 1.12 billion Swiss francs ($1.2 billion).