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Biosimilars

How do Drugs and Biologics Differ?
November 10, 2010

A biologic is manufactured in a living system such as a microorganism, or plant or animal...

Why is Patient Safety A Concern in the Biosimilars Debate?
November 10, 2010
FDA Public Hearing: Approval Pathway for Biosimilar and Interchangeable Biological Products
November 1, 2010

In this presentation, BIO urges the Food and Drug Administration to prioritize patient safety...

What Arguments Were Made in Genentech’s Citizen Petition on Biosimilars?
May 27, 2010

On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug...

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Letters, Testimony & Comments

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
December 31 2011
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on...
Biosimilar User Fees: BIO Testifies at Biosimilar User Fee Public Hearing
December 16 2011
Dear Sir/Madam: On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee...
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...
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...
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...
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Press Releases

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...
Congressman Price 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...
Representative Capuano 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...
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