Press Releases

March 25 2014

The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF)...

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...

March 29 2012

Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization...

February 15 2012

The bill will modernize the FDA and accelerate patient access to cures and new treatments.

February 9 2012

BIO President and CEO Jim Greenwood issued the following statement regarding the newly...

May 4 2011

BIO announces selection of Congressman Fred Upton (R-MI) as Legislator of the Year for 2010 -...

May 4 2011

The Biotechnology Industry Organization (BIO) announced today its selection of Representative...

May 4 2011

The Biotechnology Industry Organization (BIO) announced today its selection of Congressman...

May 4 2010

A new report issued by the Biotechnology Industry Organization underscores how biotechnology...

October 14 2014
The Biotechnology Industry Organization (BIO) appreciates this fifth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin.
October 6 2014
The Biotechnology Industry Organization (“BIO”) thanks the Food and Drug Administration (“FDA”) for the opportunity to submit comments on the above-referenced Draft Guidance for Industry: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (August 2014) (“Exclusivity Draft Guidance” or “Draft Guidance”).
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”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).
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.