Home » Health Care

Letters, Testimony & Comments

BIO Comments on Colombia Biologics and Biosimilars Regulations
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of...
February 22 2013
Letter Supporting Florida House Bill 365; Pertaining to requirements for pharmacist to dispense substitute biological product
Representative Matt Hudson Florida House of Representatives 402 South Monroe Street Tallahassee, FL 32399 Dear Representative Hudson...
February 1 2013
Statement in Support of Virginia H.B. 1422
In December 2012, Virginia House Delegate John M. O'Bannon, III introduced the Interchangeable biosimilar biological products bill (H...
January 10 2013
BIO Comments on EMA Guideline on Biosimilar Quality Issues
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA or Agency) for the opportunity to submit...
November 30 2012
Biosimilar Patent Certification: University Associations Ask FDA to Not Undermine Their Patent Rights
Dear Commissioner Hamburg: We are writing on behalf of the following higher education associations in consideration of issues raised...
November 5 2012
Canada's Trans-Pacific Partnership (TPP) Entry: BIO Submits Comments to USTR
I. Agricultural and Animal Biotechnology The Government of Canada has long been a trusted ally to the United States on agricultural...
September 3 2012
Unique Names for Biosimilar Products: Letter to Commissioner Hamburg
July 3 2012
Biosimilars: BIO Comments on FDA's Biosimilars User Fee Cover Sheet
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 13 2012
FDA Public Meeting: Approval Pathway for Biosimilar and Interchangeable Biological Products
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...
May 11 2012
Biosimilars: BIO Comments on Questions and Answers Regarding Implementation of BPCIA
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
Biosimilars: BIO Comments on Quality Considerations
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
Biosimilars: BIO Comments on Scientific Considerations
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
March 29 2012
Letter to the Texas Health and Human Services Commission Regarding Proposed Specialty Pharmacy Rule
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health...
March 1 2012
Biologics: BIO Comments on EMA 'Concept Paper on the Revision of the Guideline on Similar Biological medicinal Product"
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments...
February 29 2012
Biologics: EMA Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substance: Non-clinical and Clinical Issues
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on...
December 31 2011
Biosimilar User Fees: BIO Testifies at Biosimilar User Fee Public Hearing
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
BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA)
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
BIO Submits "Guideline on similar biological medicinal products containing monoclonal antibodies" Comments to the European Medicines Agency (EMA)
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
BIO Comments on the Food and Drug Administration Approval Pathway for Biosimilar and Interchangeable Biological Products
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
BIO Testifies on Importance of Data Exclusivity and Patent Protection in Pathway for Approval of Biosimilars
July 15, 2009
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
Patients, Physicians, Researchers and Other Stakeholders Urge Senate HELP Committee to Include Pathway for Biosimilars in Health Care Reform
June 23, 2009
June 23 2009
FTC Biosimilars Report Rebuttal
June 10, 2009
June 10 2009
FDA Response to Health Subcommittee of House Energy and Commerce Committee on Follow-On Biologics
September 18, 2008
September 18 2008
BIO provides answers to House Energy and Commerce Subcommittee on Health questionnaire on follow-on biologics
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
Data Exclusivity Period Length and Federal Government Savings from Enactment of the Biologics Price Competition and Innovation Act of 2007
June 27, 2007
Authors: Joseph Golec, John Vernon, and Ted Buckley
June 27 2007
Testimony before the House Committee on Energy and Commerce, Health Subcommittee
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
Follow-On Biologics: An Introduction
March 1, 2007
March 1 2007
Comments to the proposed changes to the Current Procedural Terminology ("CPT") codes related to the administration of drugs and biologicals
August 10, 2004
Joint letter with Plasma Protein Therapeutics Association (PPTA) concerning intravenous immune globulin ("IVIG")
August 10 2004

Letters, Testimony & Comments

BIO Comments on Colombia Biologics and Biosimilars Regulations
February 22 2013
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of...
Letter Supporting Florida House Bill 365; Pertaining to requirements for pharmacist to dispense substitute biological product
February 1 2013
Representative Matt Hudson Florida House of Representatives 402 South Monroe Street Tallahassee, FL 32399 Dear Representative Hudson...
Statement in Support of Virginia H.B. 1422
January 10 2013
In December 2012, Virginia House Delegate John M. O'Bannon, III introduced the Interchangeable biosimilar biological products bill (H...
BIO Comments on EMA Guideline on Biosimilar Quality Issues
November 30 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA or Agency) for the opportunity to submit...
Biosimilar Patent Certification: University Associations Ask FDA to Not Undermine Their Patent Rights
November 5 2012
Dear Commissioner Hamburg: We are writing on behalf of the following higher education associations in consideration of issues raised...
More Letters, Testimony & Comments →

Press Releases

BIO Submits Comments on FDA Draft Guidances on Biosimilars
April 17 2012
Washington, D.C. (April 17, 2012) – The Biotechnology Industry Organization (BIO) submitted comments yesterday...
BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA
March 29 2012
Washington, D.C. (March 29, 2012) – Sara Radcliffe, Executive Vice President of Health at the Biotechnology...
TREAT Act Offers Renewed Hope for Patients
February 15 2012
Washington, DC (February 15, 2012) – Today, the Biotechnology Industry Organization (BIO) praised Sen. Kay...
Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO
February 9 2012
Patient Safety Must Remain Top Priority Washington, D.C. (February 9, 2012) — Biotechnology Industry...
Representative Upton Honored as BIO Legislator of the Year
May 4 2011
WASHINGTON, D.C. (Tuesday, May 04, 2011) - The Biotechnology Industry Organization (BIO) announced today its...
More Press Releases →