Amgen files BLA for ABP 501 (adalimumab biosimilar) at FDA.

Amgen announced the submission of a Biologics License Application (BLA) with the FDA for ABP 501, a biosimilar candidate to Humira (adalimumab). Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen's first BLA submission using the 351(k) biosimilar pathway.

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-alpha monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases. Amgen's BLA submission includes analytical, clinical and pharmacokinetic data. Phase III comparative efficacy and safety studies were 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.

Comment: AbbVie claims that Humira patents (14 patents) extend for formulation to 2022 and patents (24 patents) for manufacturing to 2027 and for method of treatment to 2022.