FDA Approves Amgen’s BKEMV, the First Eculizumab Biosimilar

On May 28, 2024, the FDA approved Amgen’s BKEMV (eculizumab-aeeb), the first approved biosimilar of Alexion’s SOLIRIS (eculizumab).  BKEMV was approved by the FDA as a 300 mg/30 mL (10 mg/mL) injection, for intravenous use in a single-dose vial as interchangeable with SOLIRIS.  The product is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) or atypical hemolytic uremic syndrome (aHUS), both rare diseases.  Sarah Yim, director of the Office of Therapeutics Biologics and Biosimilars, stated “[t]he FDA is committed to help facilitate the development of safe and effective interchangeable biosimilar treatments that can expand access for individuals with rare diseases whose current treatment options are limited.”

Alexion’s BPCIA case against Amgen regarding Amgen’s eculizumab biosimilar remains pending in the District Court for the District of Delaware.  As we previously reported, on May 6, 2024, Alexion’s motion for a  preliminary injunction was denied.  Alexion has appealed the denial of its preliminary injunction motion to the Federal Circuit.  Alexion also filed with the district court an emergency motion for an injunction pending resolution of the appeal, and for a temporary restraining order pending resolution of that motion.  Briefing on that motion is to be completed this week.