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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. ....

United States , European Commission , Committee For Medicinal Products Human Use , European Union , European Medicines Agency , Outlook Therapeutics , Bio Thera Solution , Medicinal Products , Human Use ,

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. ....

Choroidal Neovascularization , Genentech Lucentis , Genentech Avastin , Drug Administration , Mcdonnell Boehnen Hulbert Berghoff , Mcdonnell Boehnen Hulbert , Age Related Macular Degeneration , Macular Edema Following Retinal Vein Occlusion , Myopic Choroidal Neovascularization , Bio Thera Solution ,

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. ....

New Zealand , Yoganand Chillarige , Li Zhang , Chiara Gasteiger , Bevacizumab Biosimilar , Drug Administration , University Of Chicago Medicine , University Of Auckland , Biosimilars Adoption , Chicago Medicine , Additional Bevacizumab , Bio Thera Solution , Medicare Advantage ,

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

FDA Approves Bio-Thera Solutions' Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®
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Li Zhang , United States , Shengfeng Li , Wechat Bio Thera , Prnewswire Bio Thera Solutions Ltd , Bio Thera Solutions , Drug Administration , Bio Thera Solutions Ltd , Genentech Inc , Biogen Inc , Bio Thera Solution , Thera Solutions , United States Food ,

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. ....

United States , Li Zhang , Drug Administration , Bio Thera Solution ,