ABP 501 (adalimumab biosimilar) BLA filing accepted at FDA with Biosimilar User Fee Act (BsUFA) target action date of 25 September 2016-Amgen
January 2016-Amgen announced that the FDA has accepted for review Amgen's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).The BLA, submitted on 25 November 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.
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.
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