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BMS, Ono take Amgen to task as FDA's Opdivo biosimilar decision looms
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Fusion42 · 16 September 2026 · Fusion42 review
Bristol Myers Squibb and Ono Pharmaceutical have sued Amgen for patent infringement over its proposed biosimilar to Opdivo, with the FDA decision on Amgen's application expected by the end of the year. The lawsuit challenges Amgen's attempt to market its biosimilar before the expiration of key patents that protect Opdivo's active ingredient and method of treatment.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 16 Sep 2026 and 17 Sep 2026.
◆ ◆ The Wire takeaway
Patent lawsuits are blocking or delaying biosimilar launches in oncology, which means you should prepare for a tighter US entry window and higher legal risk if you build biosimilars to cancer drugs. Watch FDA decisions closely to time your market moves.
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2 sources · first reported 16 Sep 2026 · latest 17 Sep 2026
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