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Samsung Bioepis European Medicines Agency (EMA) Pharmaceutical Industry

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Ranibizumab Biosimilar Program Updates

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This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular...more

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EMA Reviews Samsung Bioepis’ Lucentis Biosimilar For Eye Diseases

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Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an...more

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Biosimilar Market Updates

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Shanghai Henlius biosimilar antibody developments - On March 9, 2020, Shanghai Henlius Biotech, Inc. announced that its investigational new drug application has been accepted by China’s National Medical Products...more

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Samsung Bioepis and Biogen Announces Pooled Analysis of Three Anti-TNF Biosimilars

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Yesterday, Samsung Bioepis and Biogen announced pooled analysis results that will be presented this week at the 2018 Annual European Congress of Rheumatology (EULAR). Data from three separate Phase III randomized,...more

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CHMP Adopts Positive Opinions on BI’s CYLTEZO® and Samsung Bioepis’s ONTRUZANT®

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On September 15, Boehringer Ingelheim (BI) and Samsung Bioepis each issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...more

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Samsung Bioepis Receives EU Marketing Authorization for Adalimumab Biosimilar

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Yesterday, Biogen announced that the European Commission has granted marketing authorization for Imraldi® (also known as SB5). Imraldi® is a biosimilar for Humira® (adalimumab). ...more

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EMA Committee Issues Positive Opinion for Biogen’s Adalimumab Biosimilar Candidate

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According to a Biogen press release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Biogen’s Imraldi®, a proposed biosimilar to AbbVie’s Humira®...more

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