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Food and Drug Administration

BioBytes: What are biosimilars?

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

BIO Co-Sponsors February FDA/DIA Workshop
BIO Co-Sponsors February FDA/DIA Workshop!
Preemption of Liability Litigation on FDA-Regulated Products
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.

Realizing the Value of FDA-Approved Therapies

Letters, Testimony & Comments

Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
Data Standards: BIO Comments on Development of Prioritized Therapeutic Data
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
IRB: BIO Comments on Draft Guidance for IRBs
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
More Letters, Testimony & Comments →

Press Releases

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...
BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations
February 1 2012
Washington, D.C. (February 1, 2012) – Richard Pops, Chairman and CEO of Alkermes plc, testified today on behalf...
BIO Statement on “Food Labeling” Petition to FDA
October 4 2011
Washington, D.C. (October 4, 2011) – A coalition of anti-technology groups under the moniker “Just Label...
BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
September 1 2011
Washington, D.C. (September 1, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
Hill Leadership: Support Science-Based Assessments by FDA
August 3 2011
Washington, D.C. (August 3, 2011) – In a letter to Congressional Leadership, the Biotechnology Industry...
More Press Releases →