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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FDA Provides a Snapshot of the Biosimilar Development Programs
By C. Nichole Gifford February 8, 2017 Comments are off
Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team...

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Tagged with: BSUFA II, FDA, Interchangeability, Regulatory

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FDA Issues Draft Guidance on Demonstrating Interchangeability
By Seth Cockrum January 20, 2017 Comments are off
Introduction The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological...

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Tagged with: BPCIA, FDA, Featured, Guidance, Interchangeability, Labeling, Regulatory

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FDA Issues Final Guidance on Non-Proprietary Naming of Biological Products
By Rachel M. Echols January 15, 2017 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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Tagged with: FDA, Featured, Guidance, Labeling, Naming, Regulatory

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