FDA Accepts Amgen’s ABP 501 Biosimilar for Review

January 28, 2016
Pharmaceutical Technology Editors

Amgen announces FDA will review the company’s BLA for ABP 501.

Amgen announced on Jan. 25, 2016 that FDA has accepted for review Amgen's biologics license application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

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.

The acceptance pushes Amgen one step closer to FDA approval for the biosimilar. AbbVie, the original developer of adalimumab, has said it has plans to aggressively defend the drug’s patents, preventing the biosimilars from coming to market until 2022. Amgen has pushed back, saying they plan to have their adalimumab biosimilar on the market between 2017 and 2019.

The United States Patent and Trademark Office recently denied Amgen’s petition to challenge claims on Humira’s ‘157 patent, which focuses specifically on the antibody formulation of the drug. Amgen said that the company still plans to challenge the legality of Humira’s patents.  

Source: Amgen