Managed Healthcare Executive June 1, 2024
The FDA has made two approvals this week: the first interchangeable biosimilar of Soliris and another indication for Breyanzi for mantel cell lymphoma. The agency has delay a decision on Dupixent in COPD and has set goal dates for zolbetuximab in gastric cancer and zanidatamab in bile duct cancer.
FDA Approves First Interchangeable Biosimilar of Soliris
The FDA has approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab). Bkemv is approved for two of Soliris indications: to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and patients with atypical hemolytic uremic syndrome (aHUS).
PNH is an ultra-rare blood disorder that is characterized by the destruction of red blood cells. Atypical hemolytic uremic syndrome is a rare genetic disease...
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