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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