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USFDA gives nod to first interchangeable biosimilar for two rare diseases

USFDA gives nod to first interchangeable biosimilar for two rare diseases
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MIL-OSI USA: FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

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FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

FDA approved Bkemv as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH); and atypical hemolytic uremic syndrome (aHUS).

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