Amgen Announces Success in Humira Biosimilar Clinical Studies

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Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.


Amgen announced on Feb. 3, 2015 that its Phase III study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with Humira (adalimumab) in patients with moderate-to-severe rheumatoid arthritis (RA) met primary and secondary endpoints. The primary endpoint compared the ACR20 measurements (20% or greater improvement in American College of Rheumatology [ACR] assessment) at 24 weeks. Compared with adalimumab, ABP 501 was within the prespecified margin, proving its equivalence, along with safety and immunogenicity. Key secondary endpoints included ACR50, ACR70, and DAS 28-CRP, or Disease Activity Score Calculator, which is an instrument used to measure disease activity in patients with RA.

Developed as a biosimilar candidate to the anti-TNF-α monoclonal antibody, adalimumab, ABP 501 was tested in a randomized, double-blind, active-controlled study to evaluate its safety, efficacy, and immunogenicity. The study compared 264 randomized patients receiving ABP 501 40 mg subcutaneous every two weeks with 262 randomized patients receiving adalimumab 40 mg subcutaneous every two weeks The primary endpoint ACR20 was assessed at week 24, with a safety follow-up period through to week 26.


Amgen is positioned to become a key competitor in the Humira biosimilar market, which includes Boehringer Ingelheim; Novartis; Coherus, which announced that its biosimilar met its primary endpoint when compared to Humira in clinical studies; and Zydus Cadila, which recently launched the first adalimumab biosimilar, Exemptia, in India.

Amgen also announced success in ABP 501 studies for the treatment of psoriasis. However, there may be competitors who better hit the mark when it comes to the treatment of the autoimmune disease. In January 2015, FDA approved Novartis’ Cosentyx (secukinumab) for the treatment of plaque psoriasis, noticing a “significantly superior” efficacy over Enbrel (etanercept), which is the most commonly used TNF inhibitor in psoriasis treatments.