Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s...
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 Comments are off
The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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By C. Nichole Gifford Comments are off
FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017. Renflexis® is the fifth biosimilar...
Tagged with: Biogen, Celltrion, FDA, Inflectra®, Infliximab, Janssen, News, Regulatory, Remicade®, Renflexis®, Samsung Bioepsis
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By C. Nichole Gifford Comments are off
Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team...
Tagged with: BSUFA II, FDA, Interchangeability, Regulatory
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By Seth Cockrum Comments are off
Introduction The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological...
Tagged with: BPCIA, FDA, Featured, Guidance, Interchangeability, Labeling, Regulatory
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By Rachel M. Echols Comments are off
On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming...
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