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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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Sarah Yim , Bkemv To Amgen Inc , Drug Administration , Office Of Therapeutic Biologics , Therapeutic Biologics , Drug Evaluation , Govt Run Janaushadhi , Dry Eye , Boxed Warning , Bkemv Risk Evaluation , Mitigation Strategy ,

Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

THOUSAND OAKS (dpa-AFX) - The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), developed by British ....

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Biosimilar for 2 Rare Diseases Accepted by FDA

Biosimilar for 2 Rare Diseases Accepted by FDA
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Positive phase 3 results for psoriasis antibody injection support NDA submission in China

Positive phase 3 results for psoriasis antibody injection support NDA submission in China
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