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RegisterBiosimilars [Design Issues]
❝ 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The U.S. Food and Drug Administration issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.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.
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Complete thread:
- Biosimilars M.Vasu 2011-11-24 14:01
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biosimilars Helmut 2011-11-24 14:44
- Biosimilars M.Vasu 2011-11-28 12:33
- Healthy subjects vs. patients Helmut 2011-11-28 12:56
- Biosimilars drgunasakaran1 2012-02-06 13:57
- Biosimilars Ben 2011-12-16 19:04
- Biosimilars M.Vasu 2011-11-28 12:33
- Biosimilars Chiku 2012-02-03 06:43
- Biosimilarsdrgunasakaran1 2012-02-10 11:33
- Biosimilars Chiku 2012-02-10 12:03
- Biosimilars Kumarnaidu2 2021-10-22 07:53
- Biosimilars Chiku 2012-02-10 12:03
- Biosimilarsdrgunasakaran1 2012-02-10 11:33
- Biosimilars Helmut 2011-11-24 14:44
Ing. Helmut Schütz