Letters, Testimony & Comments
BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products....
March 21 2013
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of...
February 22 2013
Representative Matt Hudson
Florida House of Representatives
402 South Monroe Street
Tallahassee, FL 32399
Dear Representative Hudson...
February 1 2013
In December 2012, Virginia House Delegate John M. O'Bannon, III introduced the Interchangeable biosimilar biological products bill (H...
January 10 2013
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA or Agency) for the opportunity to submit...
November 30 2012
Dear Commissioner Hamburg:
We are writing on behalf of the following higher education associations in consideration of issues raised...
November 5 2012
I. Agricultural and Animal Biotechnology
The Government of Canada has long been a trusted ally to the United States on agricultural...
September 4 2012
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 14 2012
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...
May 11 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
March 29 2012
February 22, 2012
Texas Health and Human Services Commission
Attn: Stacey Johnston
Policy Analyst
Medicaid/Children’s Health...
March 1 2012
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments...
February 29 2012
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on...
December 31 2011
Dear Sir/Madam:
On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee...
December 16 2011
June 9, 2011
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
May 31, 2011
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the...
May 31 2011
December 23, 2010
Re: Docket No. FDA-2010-N-0477, Request for Comments on the Food and Drug Administration Approval Pathway for Biosimilar and...
December 23 2010
July 15, 2009
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
June 23, 2009
June 23 2009
September 18, 2008
September 18 2008
May 2, 2008
Dear Chairman Pallone and Ranking Member Deal:
On behalf of the Biotechnology Industry Organization (BIO), I am writing to thank you...
May 2 2008
June 27, 2007
Authors: Joseph Golec, John Vernon, and Ted Buckley
June 27 2007
April 17, 2007
Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for the opportunity to testify before you today...
April 17 2007
August 10, 2004
Joint letter with Plasma Protein Therapeutics Association (PPTA) concerning intravenous immune globulin ("IVIG")
August 10 2004
Letters, Testimony & Comments
March 21 2013
BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products. Peru is a growing market for biotechnology products and with the implementation of the US-Peru TPA, it promises to become an even bigger market.
February 22 2013
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of biological origin. Many elements of the third draft appear to have addressed BIO's previous comments with respect to clarity of structure and definitions of terms, as well as expectations for data requirements.
February 1 2013
BIO supports passage of Florida House Bill 365, which provides requirements for pharmacist to dispense substitute biological products that are determined to be interchangeable for prescribed biological product.
January 10 2013
In December 2012, Virginia House Delegate John M. O'Bannon, III introduced the Interchangeable biosimilar biological products bill (H.B. 1422). This proposed legislation seeks to permit pharmacists to dispense a biosimilar drug that has been licensed by the U.S. Food and Drug Administration as interchangeable with a prescribed biological product unless the prescriber indicates such substitution is not authorized or the patient insists on dispensing of the prescribed biological product.
November 30 2012
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