Biosimilars

We have used the biological processes of microorganisms for 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products.

Today, the biotechnology industry is enjoying more success and influence than ever before. Our industry’s innovations continue to improve the lives of people worldwide, and the advancement of these innovations is supported by the work of BIO.

In order to ensure that new pioneer biotechnology products continue to reach patients and physicians, any statutory pathway for the approval of follow-on biologics must protect patient safety and preserve incentives to innovate.

Biotechnology, the combination of biology and technology, includes biologic applications, diagnostic tools and businesses that improve everyday life by providing solutions to some of life's most vexing problems.

Authors: Henry Grabowski, Iain Cockburn, Genia Long, Richard Mortimer, Scott Johnson

What happens in Washington influences biotechnology progress every bit as much as what happens on Wall Street or in the lab.

Has a member of your family been vaccinated against hepatitis B? Do you know someone who has diabetes? Has anyone in your family had heart disease?

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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”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.