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Biosimilars

How do Drugs and Biologics Differ?

A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology.

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

In this presentation, BIO urges the Food and Drug Administration to prioritize patient safety and incentives for innovation at a public hearing on biosimilars.

What Arguments Were Made in Genentech’s Citizen Petition on Biosimilars?

On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA) with respect to a biotechnology product that relies, directly or indirectly, on trade secret and confidential commercial data and information of an innovator.

How Has Europe Approached Biosimilars?

The European Medicines Agency (EMEA), the European equivalent to the Food and Drug Administration (FDA), has implemented an approval scheme that specifically distinguishes between biosimilars (follow-on biologics) and generic drugs.

What Legal Issues are Presented by Biosimilars?
Healing, Fueling, Feeding: How Biotechnology Is Enriching Your Life.

Biotechnology is all around us and is already a big part of our lives, providing breakthrough products and technologies to combat disease, reduce our environmental footprint, feed the hungry, and make useful products.

Podcast on BIO's Public Policy Priorities for 2010

Danny Levine of the Burrill Report conducted a podcast with BIO President & CEO Jim Greenwood today on BIO's public priorities for 2010.

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. 

Data Exclusivity and Biotech Competition: Separating Fact from Fiction

Myths abound regarding data exclusivity and the ability of an innovator to extend the period of data exclusivity as provided in the health care reform bill passed by the U.S. House of Representatives and legislation currently under consideration in the Senate.

Follow-On Biologics Presentation
Hans Sauer and Professor Chris Holman: The Role of Patents in a Pathway for the Approval of Biosimilars
Jim Greenwood guest appearance on CNBC’s “Squawk Box” during this morning’s “Health Care Summit” special
Biotech in the Blogosphere
Clearing Another Hurdle on the Pathway to Biosimilars

Letters, Testimony & Comments

Biosimilars: BIO Comments on FDA's Biosimilars User Fee Cover Sheet
May 14 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
FDA Public Meeting: Approval Pathway for Biosimilar and Interchangeable Biological Products
May 11 2012
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...
Biosimilars: BIO Comments on Questions and Answers Regarding Implementation of BPCIA
April 16 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
Biosimilars: BIO Comments on Quality Considerations
April 16 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
Biosimilars: BIO Comments on Scientific Considerations
April 16 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
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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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