Amgen "Clears First Regulatory Hurdle for Biosimilar Production"

February 2, 2016

February 02, 2016.

FDA News reports that Amgen "has cleared its first regulatory hurdle for biosimilar production with the FDA’s acceptance of its Biologics License Application (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 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.