On February 28, 2025, Amgen filed three IPRs against Bristol-Myers Squibb’s patents covering methods of treatment using a combination of Opdivo® (nivolumab), an anti-PD-1 antibody, and Yervoy® (ipilimumab), an anti-CTLA-4 antibody: IPR2025-00601 challenging U.S. Patent No. 9,856,320, IPR2025-00602 challenging U.S. Patent No. 10,174,113, and IPR2025-00603 challenging U.S. Patent No. 11,332,529. Amgen is currently conducting Phase III trials for ABP 206, an investigational biosimilar of Opdivo®. These are the first patents related to Opdivo® that have been challenged by a potential biosimilar competitor.
On December 27, 2024, the FDA approved a subcutaneous version of Opdivo® called Opdivo Qvantig™ (nivolumab; hyaluronidase-nvhy).
Bristol-Myers Squibb reported U.S. sales of $5.35B for Opdivo® in 2024.
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The author would like to thank April Breyer Menon for her contributions to this article.
