Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s...
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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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The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end...
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FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017. Renflexis® is the fifth biosimilar...
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Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team...
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Introduction The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological...
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On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming...
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