Amgen Sued Over Proposed Biosimilar for Opdivo

Bristol Myers Squibb (BMS) and Ono Pharmaceutical are suing Amgen over claims that its proposed biosimilar for Opdivo would infringe on seven patents covering the originator drug's active ingredient and method of treatment.

The lawsuit alleges that Amgen aimed to market its biosimilar ahead of the expiration of key U.S. patents, which BMS and Ono hope to win orders enjoining Amgen from manufacturing or selling its version of Opdivo while their patents remain in place.

According to BMS' latest annual report, the company has set an estimated minimum market entry date for U.S. Opdivo copycats in 2028.