The US Food and Drug Administration (FDA) has accepted for review Amgen’s biologics license application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab). Humira was AbbVie’s best-selling drug in 2014 with revenues of $12.5 billion.

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. 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).

The BLA, submitted on Nov. 25, 2015, is based on 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 FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016, for ABP 501.

Source: Amgen