Amgen's biosimilar Humira meets in RA equivalence trial

Amgen Inc. (NASDAQ:AMGN) said its ABP 501 met the primary endpoint of equivalence, as measured by ACR20 at week 24, to Humira adalimumab from AbbVie Inc. (NYSE:ABBV) in a Phase III trial to treat moderate to severe rheumatoid arthritis (RA). ABP also met its secondary endpoints and showed safety and immunogenicity comparable to Humira, Amgen said.

Amgen spokesperson Kelley Davenport said trials of ABP 501 to treat RA and plaque psoriasis will be the basis for global regulatory submissions, and that Amgen hopes the trials will support approval in Humira's other indications "when reviewing the totality of evidence," reiterating her comments from last October when the compound showed equivalence to Humira in a Phase III trial to treat plaque psoriasis (see BioCentury Extra, Oct. 8, 2014). ...