Amgen has submitted a biologics license application (BLA) with the US Food and Drug Administration (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-α monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases.

Humira is AbbVie’s top-selling drug. It had 2014 sales of $12.5 billion, accounting for 63%,of the company’s 2014 sales of $19.960 billion.

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.

The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (US) and adalimumab (EU).

Source: Amgen