Ph III study of Amgen's Humira biosimilar ABP 501 meets endpoint in psoriasis

9 October 2014
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US biotech major Amgen (Nasdaq: AMGN) says its Phase III study evaluating the efficacy and safety of its biosimilar candidate ABP 501 compared with AbbVie’s (NYSE: ABBV) blockbuster drug Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.

Amgen’s shares rose 2.9% to $140.05 in afternoon trading on Wednesday, and shares of AbbVie gained 2.7% to $58.16.

The primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment. At week 16, the PASI percent improvement from baseline was within the pre-specified equivalence margin for ABP 501 compared to adalimumab. Safety and immunogenicity of ABP 501 were comparable to adalimumab.

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