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On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
By Benjamin R. Holt Comments are off
On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
Tagged with: aBLA, Amgen, BPCIA, Enbrel®, etanercept, Eticovo, FDA, Featured, Patent Dance, Regulatory, Samsung Bioepis, Sandoz
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By Aydin Harston Comments are off
FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.FDA approves...
Tagged with: BPCIA, EMA, FDA, Featured, Regulatory
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By Aydin Harston Comments are off
Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States. Pfizer launches Retacrit®, an epoetin alfa...
Tagged with: BPCIA, EMA, FDA, Featured, Regulatory
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By Aydin Harston Comments are off
European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...
Tagged with: BPCIA, EMA, FDA, Featured, Regulatory
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By Aydin Harston and Andrew Storaska Comments are off
FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)...
Tagged with: BPCIA, EMA, FDA, Regulatory
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By Aydin Harston and Andrew Storaska Comments are off
European Medicines Agency approves second trastuzumab and third insulin glargine biosimilars FDA has not approved any biosimilar...
Tagged with: BPCIA, EMA, FDA, Regulatory
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By Aydin Harston and Andrew Storaska Comments are off
U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars U.S. Food & Drug...
Tagged with: BPCIA, EMA, FDA, Regulatory
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By Aydin Harston and Andrew Storaska Comments are off
European Medicines Agency newly approves two adalimumab biosimilars U.S. Food & Drug Administration approves first bevacizumab...
Tagged with: BPCIA, EMA, FDA, Regulatory
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By D. Lawson Allen Comments are off
According to a new report by RAND Corporation, biosimilars could save $54 billion in healthcare spending on biologics over the next ten...
Tagged with: Biologics, BPCIA, Medicare, Regulatory
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