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European Biosimilar Regulatory Update | Goodwin - Vimarsana News

European Biosimilar Regulatory Update | Goodwin

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.

FDA Approves Yet Another Interchangeable Biosimilar and Another Biosimilar | McDonnell Boehnen Hulbert & Berghoff LLP - Vimarsana News

FDA Approves Yet Another Interchangeable Biosimilar and Another Biosimilar | McDonnell Boehnen Hulbert & Berghoff LLP

On October 3, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Biogen's Byooviz (ranibizumab-nuna) as an interchangeable biosimilar to Genentech's Lucentis...

Biosimilars Month in Review: December 2023 - Vimarsana News

Biosimilars Month in Review: December 2023

The biosimilars month in review highlights interviews with experts discussing the cost-saving potential of increased biosimilars uptake in the US, a recent US Food and Drug Administration (FDA) approval, and the impact of a mandatory switch to an adalimumab biosimilar in New Zealand.

FDA Approves Bevacizumab Biosimilar Bevacizumab-tnjn for Lung, Colorectal Cancers - Vimarsana News

FDA Approves Bevacizumab Biosimilar Bevacizumab-tnjn for Lung, Colorectal Cancers

The decision was based on both clinical and non-clinical data supporting the biosimilarity of bevacizumab-tnjn (Avzivi), previously named BAT1706.

FDA Approves Bio-Thera Solutions' Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin® - Vimarsana News

FDA Approves Bio-Thera Solutions' Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®

/PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets,...