FDA Approves Amgen's Humira Biosim

Sep 25, 2016

Wall Street Journal

Amgen's drug, Amjevita, is the fourth biosimilar to earn FDA approval.

U.S. regulators have approved Amgen's copy of AbbVie's anti-inflammatory treatment, Humira, which was the second-biggest selling drug in 2015. 

Per the FDA, Amgen must give 180 days notice before commercially marketing the new biosimilar, meaning the earliest possible launch date is March 2017.

Additionally, following an FDA panel's endorsement of the biosim version, AbbVie filed a patent-infringement lawsuit against Amgen, seeking to block sales of the biosimilar -- a move that could further delay Amjevita's comercial availability.

Read the WSJ coverage

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