BREAKING NEWS: FDA Accepts Amgen’s Biosimilar Application for ABP 501

U.S. FDA News

Amgen announced today that FDA has accepted its Biologics License Application for ABP 501, a biosimilar of AbbVie’s Humira® (adalimumab).

Adalimumab is an anti-inflammatory medication that has been approved to treat rheumatoid arthritis, Crohn’s disease, and other conditions.  To prove that the proposed biosimilar is highly similar to the reference product, Amgen submitted Phase III clinical trial data showing that its ABP 501 has comparable efficacy, safety, and immunogenicity to adalimumab.

Stay tuned to the Big Molecule Watch for updates on Amgen’s regulatory submissions.

Download PDF

Comments are closed.