AMGN · News · 20260916N
Opdivo Biosimilar Patent Litigation
AMGEN INC · 2026-09-16 · Importance 40 · Surprise 42 · In source text
Bristol Myers Squibb and Ono Pharmaceutical sued Amgen in Delaware federal court to block the proposed biosimilar version of Opdivo. The plaintiffs allege that Amgen’s product would infringe several patents and are challenging aspects of information exchange during biosimilar development. Opdivo generated more than $5.9 billion in U.S. revenue for Bristol Myers last year, and the company expects patent exclusivity through 2028, underscoring the commercial significance of the dispute.
Key facts
- Amgen has submitted its biosimilar application for Opdivo to the FDA. source
- Bristol Myers Squibb and Ono Pharmaceutical have sued Amgen in Delaware federal court to prevent the launch of Amgen's proposed biosimilar version of Opdivo. source
- The lawsuit alleges that Amgen's proposed Opdivo biosimilar would infringe several patents held by Bristol Myers Squibb and Ono Pharmaceutical. source
- Bristol Myers Squibb and Ono Pharmaceutical are suing Amgen over its proposed Opdivo biosimilar, alleging patent infringement ahead of key expiration dates. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Amgen has submitted its biosimilar application for Opdivo to the FDA. |
| revenue | negative | contingent | — | Bristol Myers Squibb and Ono Pharmaceutical have sued Amgen in Delaware federal court to prevent the launch of Amgen's proposed biosimilar… |