News & Analysis as of August 31, 2025

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

Accord Receives Positive EMA Opinion for Two Denosumab Biosimilars

Goodwin on 4/8/2025

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

EU Biosimilar Regulatory and Launch Updates

Goodwin on 2/7/2025

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

Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Goodwin on 11/5/2018

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets....more

Amgen/Allergan & Sandoz Receive Positive CHMP Opinions

Goodwin on 3/27/2018

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

Enbrel Biosimilar in Europe and US

Patterson Belknap Webb & Tyler LLP on 12/2/2015

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

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