News & Analysis as of August 27, 2025

European Medicines Agency (EMA)

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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 -

EMA Issues Positive CHMP Opinions for Biocon’s Denosumab Biosimilars

Goodwin on 5/12/2025

Last week, Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Biocon’s two denosumab biosimilar candidates....more

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

Biosimilars: Comparison chart between Canada, US and Europe

Smart & Biggar on 12/2/2019

As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more

Biosimilars in Europe

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 7/21/2017

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more

Global Patent Prosecution Newsletter - July 2017

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 7/18/2017

Biosimilars Around the World - Last month’s Supreme Court ruling in Sandoz v. Amgen brought greater certainty to both biosimilar applicants and originators in the United States. The July 2017 issue of Sterne Kessler’s...more

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

Hogan Lovells on 7/10/2017

The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more

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