| Follow-on Biologics Have |
Their Own Twists and Turns.
Let's Follow the Straight Path
and Keep Patient Safety First. |
Current FOBs Information |
Current FOBs Information
BIO Position Statement (December 2002)
Follow-on Biotechnology Products
Read the statement
BIO Position Statement
Naming and Labeling Requirements for Biological Medicines
Read the statement. (39 KB PDF)
EMEA's draft guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance
Comments by BIO: EMEA/CHMP/42832/2005 (October 31, 2005)
Read the comments. (113 KB PDF)
EMEA Biologics Working Party Secretariat
Comments by BIO; EMEA/CHMP/BWP/49348/2005 (June 30, 2005)
Read the comments. (95 KB PDF)
Workshop on Follow-on Protein Pharmaceuticals
Follow-up comments by BIO: Docket No. 2004N-0355 (March 16, 2005)
Read the comments. (294 KB PDF)
EMEA's Draft Guideline on Similar Biological Medicinal Products
Comments by BIO; CHMP/437/04 (February 28, 2005)
Read the comments. (111 KB PDF)
Scientific Considerations Related to Developing Follow-on Protein Products
Docket No. 2004N-0355, CDER 20041115. (December 13, 2004)
Read the comments. (424 KB PDF)
Public Workshop on the Scientific Considerations Related to Developing Follow-On Protein Products
Sara Radcliffe, Managing Director, Scientific and Regulatory Affairs, Testifying on behalf of the Biotechnology Industry Organization Before the Food and Drug Administration, HHS. (Sept. 14, 2004)
Read the statement.
BIO's comments in support of a citizen petition filed by Genentech, Inc.
Submitted to the Food and Drug Administration (June 16, 2004)
Read the comments (338 KB PDF)
"Why Biotechs Might Have A Point on Resisting Generics"
by David P. Hamilton, Wall Street Journal, Mar. 3, 2004
Read the column (requires WSJ registration)
BIO Statement on European Pharmaceutical Legislation Requiring Testing for 'Biosimilar' Products
Statement by BIO President Carl B. Feldbaum (Dec. 18, 2003)
Read the statement
The Proposed Approval of Generic Biologics
Letter to Rep. Michael Bilirakis, Chairman, Energy & Commerce Cmte., Subcommittee on Health (July 26, 2001)
Read the letter
BIO's Citizen Petition
CDER response to citizen petition filed by Pfizer (May 30, 2006)
Letter from CDER director, Steven Galson, M.D., M.P.H.
Read the letter (2.6 MB PDF)
HHS Response to Citizen Petition (October 14, 2003)
Read the response (675 KB PDF)
BIO Supplement to Citizen Petition (August 8, 2003)
Read the supplement (483 KB PDF)
BIO Calls on FDA To Conduct Open, Public Discussion on Follow-on Biologics (April 24, 2003)
Read the press release
Citizen Petition
Regarding Follow-on Therapeutic Proteins (April 23, 2003)
Read the petition (742 KB PDF)
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