Boehringer's biosimilar Humira under FDA, EMA review

Boehringer Ingelheim GmbH (Ingelheim, Germany) said FDA and EMA accepted for review regulatory applications for BI 695501, a biosimilar of autoimmune drug Humira adalimumab from AbbVie Inc. (NASDAQ:ABBV). In October, Boehringer said the biosimilar met the primary endpoint of a Phase III study by showing equivalence to Humira in patients with rheumatoid arthritis.

One other biosimilar of Humira has FDA approval, but is not yet marketed. In September, FDA approved Amjevita adalimumab-atto (ABP 501) from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Sept. 23, 2016)...