Bioequivalence and Bioavailability Forum • Biosimilars

Biosimilars [Design Issues]

posted by drgunasakaran1 – 2012-02-10 12:33 (5241 d 19:12 ago) – Posting: # 8094
Views: 8,641

❝ 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The U.S. Food and Drug Administration issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.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 Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Complete thread:

Biosimilars M.Vasu 2011-11-24 14:01
- 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 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