Bristol Myers Squibb and Ono Pharmaceutical sued Amgen in Delaware federal court on September 15, seeking to block Amgen’s proposed U.S. biosimilar of Opdivo (nivolumab).
The companies allege that Amgen’s candidate, ABP 206, infringes seven U.S. patents covering Opdivo and are asking the court to prevent its launch while those patents remain in force.
The lawsuit comes as the FDA reviews Amgen’s biosimilar application. Amgen says a regulatory decision is expected by the end of 2026 and remains confident ABP 206 will be among the first Opdivo biosimilars to reach the market.
The case could delay or complicate Amgen’s entry even if the FDA approves ABP 206. It also highlights the commercial stakes:
Opdivo generated more than $5.9 billion in U.S. revenue for BMS last year.
The dispute follows recent patent setbacks for BMS in Europe, where the European Patent Office revoked additional Opdivo-related patents, increasing pressure on the company’s immuno-oncology franchise.
Sources:
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