As the FDA prepares to rule on Amgen's biosimilar version of Opdivo, the drug's original developers, Bristol Myers Squibb and Ono, are actively opposing the application. The two companies are taking steps to defend their oncology blockbuster, which has been a major revenue driver, against the first potential copycat in the U.S. market.
Amgen is aiming to join the initial wave of biosimilars to Opdivo, a treatment used across multiple cancer types. The outcome of the FDA's review will determine whether Amgen can launch a lower-cost alternative, which could reshape the competitive landscape for checkpoint inhibitors.
The source does not provide details on the specific arguments BMS and Ono are making, nor does it indicate a timeline for the FDA's decision. It only notes that the originator partners are not taking the challenge lightly, signaling a high-stakes regulatory battle ahead.