ARTICLE | Clinical News

Amgen to seek extrapolation for biosimilar Humira

October 9, 2014 2:20 AM UTC

Amgen Inc. (NASDAQ:AMGN) spokesperson Kelley Davenport said the company will seek to use clinical data for its ABP 501 biosimilar in two indications -- plaque psoriasis and rheumatoid arthritis (RA) -- and extrapolate the findings to all of the indications on the label for Humira adalimumab.

ABP 501 met the primary endpoint of equivalence to Humira from AbbVie Inc. (NYSE:ABBV) in a Phase III trial to treat patients with moderate to severe plaque psoriasis. In the 350-patient study, ABP 501 showed improvements in Psoriasis Area and Severity Index (PASI) scores that were non-inferior to Humira. Amgen said ABP 501's safety and immunogenicity were comparable to Humira's. ...