FDA to Review Amgen’s First Biosimilar Candidate

Amgen has cleared its first regulatory hurdle for biosimilar production with the FDA’s acceptance of its BLA for a biosimilar of the immunosuppressant Humira.

ABP 501 is the first of the company’s potential biosimilars that has made it this far, with two others currently undergoing pivotal trials. The BLA was submitted to the FDA in November following successful Phase 3 trials that “met their primary endpoints showing clinical equivalence” to AbbVie’s Humira, the company said.

The FDA set a Biosimilar User Fee Act (BsUFA) date of Sept. 25.