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 2, 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...

Key Documents

May 14 2012

Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...

May 11 2012

Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...

April 16 2012

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...

April 16 2012

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...

April 16 2012

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...

April 17 2012

Washington, D.C. (April 17, 2012) – The Biotechnology Industry Organization (BIO) submitted comments yesterday...

March 29 2012

Washington, D.C. (March 29, 2012) – Sara Radcliffe, Executive Vice President of Health at the Biotechnology...

February 15 2012

Washington, DC (February 15, 2012) – Today, the Biotechnology Industry Organization (BIO) praised Sen. Kay...

February 9 2012

Patient Safety Must Remain Top Priority Washington, D.C. (February 9, 2012) — Biotechnology Industry...

May 4 2011

WASHINGTON, D.C. (Tuesday, May 04, 2011) - The Biotechnology Industry Organization (BIO) announced today its...