Letters, Testimony & Comments

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
August 12 2014
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) respectfully submits these comments in response to the Generic...
January 31 2014
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the...
November 27 2013
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the...
October 31 2013
BIO appreciates this fourth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory...
October 16 2013
Biologics are complex medicines that are manufactured using living organisms.  Due to their size and complexity, biologics are...
July 8 2013
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
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the...
May 31 2011
Re: Docket No. FDA-2010-N-0477, Request for Comments on the Food and Drug Administration Approval Pathway for Biosimilar and...
December 23 2010
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
June 10 2009
Dear Chairman Pallone and Ranking Member Deal: On behalf of the Biotechnology Industry Organization (BIO), I am writing to thank you...
May 2 2008
Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for the opportunity to testify before you today...
April 17 2007
March 1 2007
Joint letter with Plasma Protein Therapeutics Association (PPTA) concerning intravenous immune globulin ("IVIG")
August 10 2004
September 19 2014
The Biotechnology Industry Organization (BIO) thanks the World Health Organization (WHO) for the opportunity to submit comments on “INN Working Doc. 14.342 - Biological Qualifier: An INN Proposal.” BIO commends WHO on the release of this proposed policy, which aims to create a consistent, global system for ensuring that all biological products are identified by a unique Biologic Qualifier (BQ).
August 12 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”
January 31 2014
The Biotechnology Industry Organization (BIO) respectfully submits these comments in response to the Generic Pharmaceutical Association (GPhA) Citizen Petition requesting the Food and Drug Administration (FDA) to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition).
November 27 2013
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the revised “Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005 Rev. 1).” BIO commends EMA on the update of this Draft Guideline, which provides an important international precedent for the development and regulation of biosimilar biological medicinal products.
October 31 2013
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the revised “Guideline on Similar Biological Medicinal Products (CHMP/437/04 Rev1).” BIO commends EMA on the update of this Draft Guideline, which provides an important international precedent for the regulation of biosimilar biological medicinal products.
March 25 2014
The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for signing legislation today designed to create a pathway for the substitution of interchangeable biologic medicines.
February 26 2014
Transparent communication important for Patients and Physicians
January 30 2014
Patients Should Be Informed if Doctor's Prescription Changed
April 17 2012
The Biotechnology Industry Organization (BIO) submitted comments yesterday to the U.S. Food and Drug Administration (FDA) on three draft guidance documents on biosimilar products.