Today, the FDA announced that it approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen® for the treatment of anemia caused by...
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FDA
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Sandoz announced last week that the FDA issued a complete response letter for its proposed biosimilar to rituximab. In the announcement,...
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European Medicines Agency approves second trastuzumab and third insulin glargine biosimilars FDA has not approved any biosimilar...
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Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing...
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Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are...
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Mumbai-based pharmaceutical manufacturer Lupin recently received FDA approval for its generic version of Roche’s Tamiflu® (oseltamivir...
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U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars U.S. Food & Drug...
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On December 14, 2017, the Federal Circuit issued an opinion in Amgen v. Sandoz, holding that the Biologics Price Competition and Innovation...
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The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb),...
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