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Amgen European Medicines Agency (EMA)

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EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars

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On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates....more

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Accord Receives Positive EMA Opinion for Two Denosumab Biosimilars

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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

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EU Biosimilar Regulatory and Launch Updates

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CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending...more

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EMA Adopts Positive Opinion for Amgen’s Eculizumab Biosimilar Candidate BEKEMV®

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On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®. BEKEMV® is a biosimilar candidate referencing Alexion’s biological product SOLIRIS® (eculizumab), which is a recombinant...more

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Amgen/Allergan & Sandoz Receive Positive CHMP Opinions

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Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing...more

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Biosimilars Update: Amgen, Allergan, Pfenex, Cinfa

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Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...more

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

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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

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Amgen Receives Positive CHMP Opinion for its Biosimilar Adalimumab

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Amgen today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has “adopted a positive opinion” for marketing of Amgen’s biosimilar adalimumab, “recommending...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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Amgen and Allergan Submit European Application for Avastin® Biosimilar

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We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also...more

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