Amgen submits BLA for Humira biosimilar

Amgen Inc. (NASDAQ:AMGN) said Wednesday it submitted a BLA to FDA for ABP 501, a biosimilar version of Humira adalimumab from AbbVie Inc. (NYSE:ABBV).

Amgen said the application includes Phase III comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. Spokesperson Kelley Davenport told BioCentury that Amgen believes its application "will support extrapolation and regulatory approval of ABP 501 in all available Humira indications when reviewing the totality of evidence required to establish biosimilarity." ...