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Samsung Bioepis European Union Prescription Drugs

Goodwin

Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector in Europe

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On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.”...more

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European Commission Approves Samsung Bioepis and Biogen’s Aflibercept Biosimilar

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

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EMA Reviews Samsung Bioepis’ Lucentis Biosimilar For Eye Diseases

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Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an...more

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