FDA offers Novartis a thumbs-up on Enbrel biosimilar as Amgen plays offense/defense simultaneously
On Friday, the FDA gave Amgen a clean bill of health for its biosimilar of AbbVie’s Humira. Today, it’s Amgen’s turn to watch a megablockbuster go under the biosimilar gun, as the FDA offers a clear thumbs up to Novartis’ knockoff of the $9 billion drug Enbrel.
Two days ahead of a panel review, FDA insiders said that Novartis’ generics division Sandoz had offered all the data needed to conclude that the copycat was good for all indications Amgen sells Enbrel for in the U.S. The FDA’s insider conclusion:
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