Amgen readies PhIII trial for first Opdivo biosimilar, with launch unlikely before 2028
The race to end Bristol Myers Squibb’s exclusivity on its megablockbuster cancer drug Opdivo (nivolumab) is beginning in earnest, with Amgen looking to kick off a Phase III trial next month for its potential biosimilar to the drug.
The randomized, double-blind trial aims to enroll 620 participants and evaluate the efficacy, safety, and immunogenicity of the biosimilar, known as ABP 206, when compared with Opdivo in subjects with treatment-naïve unresectable or metastatic melanoma, according to a new listing on a government database of trials.
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