Biosimilars [Design Issues]
❝ As far as FDA is concerned i am not able to find specific guideline for biosimiler.
The U.S. Food and Drug Administration issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.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.
- Biosimilars M.Vasu 2011-11-24 14:01 [Design Issues]
- Biosimilars Helmut 2011-11-24 14:44
- Biosimilars Chiku 2012-02-03 06:43