Biosimilars [Design Issues]

posted by drgunasakaran1  – 2012-02-10 12:33 (4013 d 14:41 ago) – Posting: # 8094
Views: 4,393

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The U.S. Food and Drug Administration issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.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

Complete thread:

UA Flag
 Admin contact
22,479 posts in 4,709 threads, 1,603 registered users;
13 visitors (0 registered, 13 guests [including 5 identified bots]).
Forum time: 03:15 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz