FDA To Rule on Amgen’s Biosimilar for AbbVie’s Humira in September

The Arthritis Advisory Committee of the US Food and Drug Administration (FDA) will review data supporting Amgen’s biologics license application (BLA) for ABP 501, a biosimilar candidate to AbbVie’s Humira (adalimumab). Humira’s was AbbVie’s top-selling drug in 2015 with sales of $14.012 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 (U.S.) and adalimumab (EU).

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 September 25, 2016 for ABP 501.

Source: Amgen

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