BMS, Ono take Amgen to task as FDA’s Opdivo biosimilar decision looms

As Amgen advances its bid to join the first wave of biosimilars to Bristol Myers Squibb and Ono’s oncology mega-blockbuster Opdivo, the originator drug’s partners are not taking the challenge lying down. The FDA is expected to make a pivotal decision regarding Amgen’s proposed biosimilar, which could significantly alter the competitive landscape in the oncology market. Given Opdivo’s substantial revenue generation, the stakes are high for all parties involved.

This impending decision underscores the ongoing tension between innovator companies and biosimilar developers, highlighting the regulatory complexities that surround the approval process. BMS and Ono’s proactive stance against Amgen reflects a broader strategy to safeguard their market share and revenue streams. As the biosimilar market continues to evolve, the outcome of this decision may set important precedents for future biosimilar approvals and the overall dynamics of pricing and access in oncology therapeutics.