Amgen became the first manufacturer to submit an application to the FDA for a nivolumab (Opdivo) biosimilar. It also was the first to be sued for patent infringement.
Last week, Amgen became the first manufacturer to disclose that they submitted an application to the FDA for a nivolumab (Opdivo) biosimilar. In doing so, Amgen also became the first manufacturer to be sued by the reference manufacturer Bristol-Myers Squibb for patent infringement.
The company disclosed the 351(k) application during a business presentation on September 10. Amgen’s product, ABP 206, is one of several publicly disclosed nivolumab biosimilar candidates. The company reported, “...for ABP 206, our biosimilar candidate to OPDIVO, our Biologics License Application with the FDA has been submitted and accepted for review. We expect an FDA action on that BLA by end of the year.”
Net 2025 US revenues for Bristol-Myers Squibb’s PD-L1 inhibitor were $5.9 billion. The intravenously administered drug was first approved in 2014 (and market exclusivity ends this year), and its main patent expiration is expected to expire in 2028. Bristol-Myers Squibb also introduced a subcutaneously administered version of Opdivo in 2024, which is approved only for specific cancers. Among other manufacturers who have publicly disclosed potential nivolumab biosimilars Sandoz, Xbrane, Henlius, and mAbxience, are in various stages of development.
Patent Infringement Suit Filed Against Amgen’s Opdivo Biosimilar
Within days of the announcement of Amgen’s FDA biosimilar application for ABP 206, Bristol-Myers Squibb initiated a lawsuit claiming infringement on at least 7 patents on their product. We estimate the earliest expected launch date for intravenously administered nivolumab biosimilars to be in 2029 based on a main patent expiration in late 2028. Based on past experience, the likelihood of a settlement between the two parties may be lower than for other prospective biosimilar manufacturers, as Amgen has been willing to go at-risk for launch in the past (specifically for its aflibercept biosimilar Pavblu, a product with a similar market size as nivolimumab).
Of further interest, Opdivo is often prescribed in combination with Yervoy (ipilimumab), which is also the focus of considerable biosimilar research (also involving Amgen). Amgen also disclosed during its business presentation that it intends to file its biosimilar application for ABP 234, its biosimilar candidate to compete with Keytruda, before the end of the year.
This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.
