Amgen starts Phase III trial with biosimilar ABP 501 for RA
Amgen will start a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from severe Rheumatoid Arthritis. The Amgen study will evaluate the safety and efficacy of Amgen�s biosimilar (ABP 501) versus AbbVie�s Humira in subjects with moderate to severe Rheumatoid Arthritis. The trial is a multicentre, double-blind, randomized, active controlled, parallel-group study. The main objective of the study is to demonstrate equivalent efficacy of ABP 501 and Humira (adalimumab) in subjects with moderate to severe Rheumatoid Arthritis with respect to risk ratio of ACR20 (20% improvement in American College of Rheumatology core set measurements) at week 24.
The patents on Humira expire in the European Union in 2016 and in the US in 2018.
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