ARTICLE | Strategy
Paving the way
How Amgen, Sandoz IP battles may unleash a flood of Humira, Enbrel biosimilars
July 25, 2016 7:00 AM UTC
Amgen Inc. and the Sandoz unit of Novartis AG are charting a course that could create competitive U.S. markets for two of the biggest prizes in the biosimilars universe, AbbVie Inc.'s Humira adalimumab and Amgen's Enbrel etanercept, which together had U.S. sales of $13.4 billion in 2015.
Unanimous advisory committee endorsements for ABP 501, Amgen's version of adalimumab, and GP2015, Sandoz's etanercept, suggest the two companies have overcome the formidable scientific and regulatory hurdles to gaining the first FDA approvals for self-injectable biosimilars. ...