Bristol Myers Sues Amgen Over Proposed Opdivo Biosimilar
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Bristol Myers Squibb (搜索) and Ono Pharmaceutical have sued Amgen in Delaware federal court to block Amgen's proposed U.S. biosimilar of the cancer immunotherapy Opdivo.
The complaint alleges Amgen's biosimilar would infringe seven U.S. patents, and seeks to bar sales while those patents remain in force.
Amgen declined to comment but said it has applied for FDA approval and remains confident it will be in the first wave of Opdivo biosimilars.
Bristol Myers Squibb (搜索) and Ono Pharmaceutical have sued Amgen in the U.S. District Court for the District of Delaware, seeking to block Amgen's proposed U.S. biosimilar of their blockbuster cancer immunotherapy Opdivo. The lawsuit, filed last week and made public on Monday, alleges that Amgen's biosimilar would infringe seven U.S. patents covering the drug, and asks the court to block sales of the biosimilar while those patents remain in force.
Opdivo earned Bristol Myers more than $5.9 billion in U.S. revenue last year, according to a company report, and Bristol Myers said in a February SEC filing that it expects to maintain patent exclusivity over Opdivo until 2028. The drug is approved in the U.S. to treat advanced or metastatic cancers, including melanoma (搜索), non-small cell lung cancer (搜索) and kidney cancer (搜索).
An Amgen spokesperson declined to comment on the lawsuit but said the company has applied for FDA approval of its drug and "remains confident" it will be "in the first wave of Opdivo biosimilars." Spokespeople for Bristol Myers and Ono did not immediately respond to requests for comment. The case is Bristol-Myers Squibb Co. v. Amgen Inc., No. 1:26-cv-01134.
Source: ET Pharma