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Alteogen’s Aflibercept Biosimilar Receives Positive CHMP Opinion

​​​​​​​We previously reported that South Korean biopharmaceutical company Alteogen submitted its Marketing Authorization Application to the European Medicines Agency (“EMA”) for ALT-L9, what has since been named EYLUXVI. ...more

Biosimilar Manufacturers to Expand Offerings in Europe and Japan

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. ...more

EMA Seeks Input on a “Tailored Clinical Approach” in Biosimilar Development

On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach in biosimilar development....more

Accord Receives Positive EMA Opinion for Two Denosumab Biosimilars

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

European Commission Approves Celltrion’s AVTOZMA (CT-P47)

​​​​​​​On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®....more

European Biosimilar Regulatory Update

In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab....more

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