Today, the FDA announced that it approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen® for the treatment of anemia caused by...
FDA
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By Seth Cockrum Comments are off
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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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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Global Approvals for Insulin Glargine Promise a More Affordable, Long-Acting Treatment for Diabetes
By Caitlin M. Wilmot Comments are off
Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing...
Tagged with: Abasaglar™, Biocon, Eli Lilly, FDA, Insulin glargine, Lantus®, Lusduna™, Merck, Mylan, Sanofi, Semglee™, trastuzumab
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By Aydin Harston Comments are off
Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are...
Tagged with: Amgen, Apotex, BLA, FDA, Federal Circuit, filgrastim, IPR, Neulasta®, Neupogen®, pegfilgrastim, PTAB
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By Caitlin M. Wilmot Comments are off
Mumbai-based pharmaceutical manufacturer Lupin recently received FDA approval for its generic version of Roche’s Tamiflu® (oseltamivir...
Tagged with: FDA, Lupin, oseltamivir phosphate, Roche, Tamiflu®
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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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By Caitlin M. Wilmot Comments are off
On December 14, 2017, the Federal Circuit issued an opinion in Amgen v. Sandoz, holding that the Biologics Price Competition and Innovation...
Tagged with: Amgen, Amgen v. Sandoz, BPCIA, FDA, Federal Circuit, filgrastim, Neupogen®, Sandoz
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By Benjamin R. Holt Comments are off
The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb),...
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