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Biosimilars

Biotech in China
February 1, 2013

The biosimilars pathway is critical for China's biotechnology industry – and this is...

Data Exclusivity Protects Innovators and Assures Investors
December 7, 2012

Biotechnology companies must have some certainty that they can protect their investment in the...

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

Safety is a priority for the development of all medicines, but biologics raise safety...

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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...
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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...
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