The U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) announced that Slovakia has beeen added to a...
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FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.FDA approves...
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Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States. Pfizer launches Retacrit®, an epoetin alfa...
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European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...
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FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)...
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Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta® (pegfilgrastim). Neulasta® was...
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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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Fujifilm Kyowa Kirin Biologics Co., Ltd. (“Fujifilm”) recently announced that it will partner with Mylan N.V. (“Mylan”) to...
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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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