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Pharmaceutical Patents Amgen European Medicines Agency (EMA)

Goodwin

Accord Receives Positive EMA Opinion for Two Denosumab Biosimilars

Goodwin on

On April 2, 2025, Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for two denosumab biosimilars: OSVYRTI and JUBEREQ. OSVYRTI is indicated for the...more

Goodwin

Amgen Has Filed for EU Approval for Herceptin® (Trastuzumab) Biosimilar

Goodwin on

During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU...more

Patterson Belknap Webb & Tyler LLP

Biosimilars in Europe: 2016 Year in Review and What’s Ahead

Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more

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