Humira biosimilar moves closer after Amgen's ABP 501 recommended

13 July 2016

The Arthritis Advisory Committee of the US Food and Drug Administration has unanimously recommended approval of ABP 501, a biosimilar being developed by US biotech Amgen (Nasdaq: AMGN) which references Humira (adalimumab), an arthritis drug marketed by US pharma major AbbVie (NYSE: ABBV).

Humira is the world’s best-selling drug and with AbbVie’s patent exclusivity in the USA due to expire at the end of this year – unless it wins ongoing legal battles to have its rights extended – the race is very much on to develop effective biosimilar versions.

Amgen was given a big boost on Tuesday when all 26 members of the FDA panel endorsed approving its ABP 501 biosimilar for all of the conditions it applied for, including rheumatoid arthritis, psoriasis, irritable bowel disease and ulcerative colitis.

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