FDA Advisory Committee will review ABP 501 (adalimumab biosimilar) on 25 September 2016- Amgen

Amgen announced that the Arthritis Advisory Committee of the FDA will review data supporting the Company's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab). The Committee will review analytical, clinical and pharmacokinetic data from studies involving ABP 501, including results from two Phase III comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

The Phase III studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission. The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of 25 September 2016 for ABP 501.