Drug Discovery and Development

Sustainable development is no small undertaking for international companies looking to meet today’s energy, food and environmental needs without compromising the Earth’s resources or its future. The innovative solution these corporate leaders are turning to is biotechnology, whether it’s to augment agricultural productivity, reduce greenhouse gas emissions, create an innovative disease therapy or diminish the use of pesticides.

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. 

Dr. Targan explains how the biotech industry is using the biology of taste to create healthier sweeteners, block bitter tastes, and help make unpleasant-tasting medicines more palatable.

What's a stem cell? Where does it come from? Learn more about how biotechnology is utilizing stem cells to create tomorrow's cures for today's diseases.

Personalized medicine will change the way patients are treated in the future - for the better. Learn more about personalized medicine - how it works, and why it could save consumers a lot of money.

This video provides a basic overview of biotechnology and its many applications in our daily lives.

Are biotech drugs really that different from traditional pharmaceuticals.  You bet they are.  Learn why here.

In this interview, BIO President and CEO Jim Greenwood explains the promise of stem cell research and why it is an important first step in bringing new therapies to patients.

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.

Letters, Testimony & Comments

April 17 2016
BIO member companies are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines.
October 22 2015
RE: Docket No. FDA–2015–D–2818 Draft Guidance for Industry: Rare Diseases—Common Issues in Drug Development   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry, entitled “Rare Diseases: Common Issues in Drug Development” (Draft Guidance).   BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.
August 16 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry, FDA Staff and Other Stakeholders entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.”
April 23 2015
BIO has filed a friend of the court brief at the Federal Circuit in the Amgen v. Sandoz case.
March 22 2015
The Biotechnology Industry Organization (BIO) thanks the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) for the opportunity to submit comments on the Notice of Proposed Rulemaking (NPRM) entitled Clinical Trials Registration and Results Submission.

Press Releases

April 6 2016
Washington, D.C. (April 6, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding today’s Senate HELP Committee mark-up of legislation as part of the Senate biomedical innovation initiative:
February 26 2016
Washington, D.C. (February 26, 2016) – The Biotechnology Innovation Organization (BIO) Executive Vice President for Health Policy Dan Durham released the following statement regarding yesterday’s White House announcement of actions to accelerate the Precision Medicine Initiative:
January 21 2016
Washington, D.C. (January 21, 2016) – The Biotechnology Innovation Organization (BIO) applauds the Industry Declaration on Combating Antimicrobial Resistance, signed by 85 biopharmaceutical and diagnostic companies and released today at the World Economic Forum in Davos, Switzerland.
November 18 2014
Washington, D.C. (November 18, 2014) – BIO issued the following statement in response to a study released today by the Tufts Center for the Study of Drug Development, which estimated the cost of developing a new prescription medicine that gains marketing approval at $2.558 billion (in 2013 dollars), including the cost of promising therapies that did not achieve FDA approval. These findings represent an increase of 145 percent, or 8.5 percent compound annual growth, since a previous study in 2003, in which Tufts estimated that cost at $1.044 billion (also in 2013 dollars).