U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars U.S. Food & Drug...
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BiosimilarsIP.com Regulatory provides articles about regulatory issues and events related to biologics and biosimilars from the FDA, the EMA and other international agencies.
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On January 3, 2018, Momenta and Mylan announced their development plan for a proposed biosimilar to Regeneron’s Eylea® whose active...
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European Medicines Agency newly approves two adalimumab biosimilars U.S. Food & Drug Administration approves first bevacizumab...
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According to a new report by RAND Corporation, biosimilars could save $54 billion in healthcare spending on biologics over the next ten...
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European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of...
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Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s...
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The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end...
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