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Biosimilars

Biotech in the Blogosphere
Clearing Another Hurdle on the Pathway to Biosimilars
Congressional Debate Continues on Data Exclusivity in Biosimilars Pathway
Victory on Biosimilars in Senate HELP Committee - But Still a Long Way from the Finish Line
The Washington Post: Special section on biotechnology
Asia as the Biosimilar Launch Pad
Guide to Biotechnology 2008

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.

2007-2008 BIO Milestones

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.

BIO Principles on Follow-On Biologics

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 Solutions for Everyday Life

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.

Why is a Significant Period of Data Exclusivity Necessary in a Pathway for Biosimilars?
The Effect on Federal Spending of Legislation Creating a Regulatory Framework for Follow-on Biologics: Key Issues and Assumptions

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

Milestones in 2006-2007

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

Everywhere You Look Biotechnology Touches Your Life

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?

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 →