July 14 (Reuters) – Rock (ROG.S) and two of its subsidiaries sued biotech company Biogen (BIIB.O) in Massachusetts federal court on Thursday, accusing his proposed similar version of Roche’s flagship rheumatoid arthritis drug, Actemra, of infringing several of their patents.
Roche, Genentech and Chugai Pharmaceutical said court that Biogen’s biosimilar would infringe patents related to the manufacture and use of their biologic drug.
A representative for Biogen declined to comment on the complaint on Friday, citing ongoing litigation. A Roche spokesperson declined to discuss the matter, but said the company believes biosimilar competition “has an important role to play in supporting the financial sustainability of healthcare systems, while leaving room for innovation”.
The U.S. Food and Drug Administration approved Actemra in 2010 to treat rheumatoid arthritis, and has since approved it for other uses, including treating hospitalized patients with COVID-19.
Switzerland-based Roche said it earned more than 2.7 billion Swiss francs — more than $3.1 billion based on current exchange rates — from sales of Actemra globally last year. , down 22% from 2021 based on lower demand for the drug as a COVID-19 treatment.
Biosimilars are versions of biologic drugs that are comparable to generics of traditional small molecule drugs. Unlike these drugs, complex biological drugs made from living cells cannot be copied exactly.
The FDA in December accepted Biogen’s request to review the proposed biosimilar.
Roche’s lawsuit claims Cambridge, Mass.-based Biogen failed to provide detailed information during the biosimilar’s approval process that was necessary to determine whether it infringed Roche’s manufacturing-related patents. of his medicine.
Roche said it believed Biogen violated its rights despite being “forced to assess Biogen’s violation based on incomplete information.”
The case is Genentech Inc v. Biogen MA Inc, US District Court for the District of Massachusetts, No. 1:23-cv-11573.
For Roche: Paul Gaffney of Williams & Connolly
Reporting by Blake Brittain in Washington
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