On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
Regulatory
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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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Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
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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Posted in:
Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
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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