Biosimilars [Design Issues]

posted by drgunasakaran1  – 2012-02-10 12:33 (4013 d 14:41 ago) – Posting: # 8094
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❝ As far as FDA is concerned i am not able to find specific guideline for biosimiler.


Dear Mr.Chiku,

The U.S. Food and Drug Administration issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Biosimilars: Q & A - Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

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