Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosim­i­lars in­dus­try has gen­er­al­ly been a dis­ap­point­ment since its in­cep­tion, with FDA ap­prov­ing 33 biosim­i­lars since 2015, just a frac­tion of those have im­me­di­ate­ly fol­lowed their ap­provals with launch­es. And more than a hand­ful of biosim­i­lars for two of the biggest block­busters of all time — Ab­b­Vie’s Hu­mi­ra and Am­gen’s En­brel — re­main ap­proved by FDA but still have not launched be­cause of le­gal set­tle­ments.

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