FDA reviewers back extrapolation for Amgen's biosimilar Humira

FDA reviewers concluded the "totality of the evidence" support the biosimilarity of ABP 501 from Amgen Inc. (NASDAQ:AMGN) to Humira adalimumab from AbbVie Inc. (NYSE:ABBV), its U.S.-licensed reference product. In briefing documents released ahead of an advisory committee meeting to discuss ABP 501, the reviewers also concluded Amgen had provided sufficient justification to support its requests to extrapolate the biosimilary to Humira's approved indications.

FDA's Arthritis Advisory Committee will meet July 12 to discuss the ABP 501 BLA, which has a Sept. 25 action date. Amgen has said it is prepared to launch ABP 501 as early as 2017, pending resolution of patent disputes. AbbVie CFO William Chase said on a March conference call the company believes its patent protection will delay biosimilar competition in the U.S. until 2022. ...