FDA accepts Amgen’s biosimilar Biologics License Application For ABP 501

February 2, 2016 9:31 PM

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

“If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to potentially expanding our robust portfolio of approved products, and further demonstrating our continued commitment to delivering high-quality medicines to patients worldwide.”

The BLA, submitted on Nov. 25, 2015, is based on analytical, clinical and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 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.

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