Bristol Myers Squibb and Ono Sue Amgen to Block Proposed Opdivo Biosimilar in US
核心洞察
Bristol Myers Squibb (搜索) and Ono Pharmaceutical filed suit in Delaware federal court seeking to block Amgen's proposed US biosimilar of the cancer immunotherapy Opdivo.
The complaint alleges Amgen's biosimilar would infringe seven US patents covering Opdivo and asks the court to bar sales while those patents remain in force.
Opdivo generated more than $5.9 billion in US revenue last year, and Bristol Myers expects patent exclusivity over the drug to run until 2028.
Bristol Myers Squibb (搜索) and Ono Pharmaceutical have sued Amgen in Delaware federal court, 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 several patents.
Bristol Myers and Ono, which co-developed Opdivo, allege that Amgen's biosimilar would infringe seven U.S. patents covering the drug, and have asked the court to block sales of the biosimilar while their patents remain in force. The case is Bristol-Myers Squibb Co. v. Amgen Inc., U.S. District Court for the District of Delaware, No. 1:26-cv-01134.
Commercial Stakes and Exclusivity Timeline
Opdivo earned Bristol Myers more than $5.9 billion in revenue in the United States last year, according to a company report. Bristol Myers said in a report filed with the U.S. Securities and Exchange Commission in February that it expects to maintain patent exclusivity over Opdivo until 2028.
Opdivo has been 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).
Amgen's Position
An Amgen spokesperson on Tuesday declined to comment on the lawsuit but said the company has applied for U.S. Food and Drug Administration approval of its drug and "remains confident" that it will be "in the first wave of Opdivo biosimilars." Spokespeople for Bristol Myers and Ono did not immediately respond to requests for comment.
Biosimilar Regulatory Context
Biosimilars are based on existing versions of biologic drugs and are comparable to generic versions of traditional pharmaceuticals. Unlike traditional drugs, complex biologics are made from living cells and cannot be copied exactly.
Prior Patent Settlement
Bristol Myers and Ono settled a patent dispute with Merck (搜索) in 2017 over its rival blockbuster cancer drug Keytruda. Under the settlement, Merck agreed to pay $625 million and a share of Keytruda royalties through 2023.