Daniel Farraye

Daniel Farraye

Goodwin

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Biocon Regulatory Approval Updates in the U.S. and Europe: Insulin Aspart and Denosumab

On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more

7/30/2025  /  Biocon , Biosimilars , Biotechnology , EU , European Commission , FDA Approval , Food and Drug Administration (FDA) , Generic Drugs , Pharmaceutical Industry , Prescription Drugs

European Commission Approves Samsung Bioepis and Biogen’s Aflibercept Biosimilar

​​​​​​​On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ.  ...more

12/2/2024  /  Biosimilars , EU , European Commission , Pharmaceutical Industry , Prescription Drugs , Samsung Bioepis
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