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Biogen Idec Pharmaceutical Industry European Medicines Agency (EMA)

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Biogen’s TOFIDENCE (tocilizumab) Approved in the EU

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​​​​​​​This week, Biogen announced that the European Commission has approved TOFIDENCE, a tocilizumab biosimilar referencing Roche’s ROACTEMRA.  TOFIDENCE was approved by the FDA in September 2023....more

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Biogen Announces EMA Acceptance of Tocilizumab Biosimilar Application

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​​​​​​​Biogen Inc. (“Biogen”) recently announced that the European Medicines Agency (EMA) has accepted the marketing authorization application for BIIB800 (BAT1806), a biosimilar candidate referencing Roche’s ACTEMRA...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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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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