Amgen Secures FDA Approval for Bkemv, the First Interchangeable Biosimilar to Soliris for Rare Blood Disorders

1. FDA Approval: The U.S. Food and Drug Administration (FDA) approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) for treating rare blood disorders.
2. Indications: Bkemv is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
3. Interchangeable Biosimilar: Bkemv is highly similar to Soliris with no clinically meaningful differences, allowing for pharmacy-level substitution.
4. Safety Profile: Bkemv has the same safety warnings and is expected to have the same adverse reactions as Soliris, including the risk of serious and life-threatening meningococcal infections.
5. Launch Plans: Amgen plans to launch Bkemv no later than March 2025.
6. Rare Diseases: PNH and aHUS are rare diseases characterized by the breakdown of red blood cells, leading to anemia, thrombosis, and kidney failure.
7. Mechanism of Action: Bkemv is a monoclonal antibody that binds to the complement C5 protein, inhibiting the breakdown of red blood cells in the bloodstream.