FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)...
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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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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Planned Clinical Trial for Aflibercept Signals Likely Future Contests Over Regeneron’s Eylea®
By Spencer Johnson Comments are off
On January 3, 2018, Momenta and Mylan announced their development plan for a proposed biosimilar to Regeneron’s Eylea® whose active...
Tagged with: aflibercept, Clinical trial, Eylea®, Formycon, Momenta Pharmaceuticals, Mylan, Regeneron
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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
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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Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
By Andrew Storaska and Aydin Harston Comments are off
European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of...
Tagged with: BPCIA, EMA, FDA, Regulatory
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