FDA Approved: BKEMV — Original Application (Amgen Inc)

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Summary

FDA approved BKEMV (eculizumab-aeeB), a biosimilar to eculizumab, developed by Amgen. The approval covers the same indications as the reference product, includi…

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Diseases / indications

• Atypical Hemolytic Uremic Syndrome
• Myasthenia Gravis
• Neuromyelitis Optica Spectrum Disorder
• Paroxysmal Nocturnal Hemoglobinuria

Drugs mentioned

• BKEMV (eculizumab-aeeB)

Snippet

ORIG AP for BKEMV (ECULIZUMAB-AEEB)