FDA Approves Amgen’s Bkemv, First Interchangeable Biosimilar to Soliris for Rare Blood Disorders ###

###
1. FDA Approval: The FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) for treating two rare blood disorders: paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
2. Indications: Bkemv is approved to reduce hemolysis in PNH patients and inhibit complement-mediated thrombotic microangiopathy in aHUS patients.
3. Interchangeable Biosimilar: Bkemv is highly similar to Soliris with no clinically meaningful differences, allowing for pharmacy-level substitution without consulting the prescriber.
4. Safety Profile: Bkemv has the same safety warnings and is expected to have the same adverse reactions as Soliris, including a Boxed Warning for increased risk of meningococcal infections.
5. Launch: Bkemv is expected to launch no later than March 2025, with pricing to be announced at that time.
6. Development: Amgen developed Bkemv as a monoclonal antibody that binds to the complement C5 protein, preventing the breakdown of red blood cells in PNH and aHUS patients.