Amgen submits MAA for Humira biosimilar

Amgen Inc. (NASDAQ:AMGN) said it submitted an MAA to EMA for ABP 501, a biosimilar version of Humira adalimumab from AbbVie Inc. (NYSE:ABBV). Amgen said it thinks ABP 501 is the first Humira biosimilar submitted to EMA.

Last week, Amgen submitted a BLA to FDA for ABP 501, with plans to pursue approval for all Humira indications. The BLA was Amgen's first biosimilar application (see BioCentury Extra, Nov. 25). ...