Follow-on Biologics (FOBs)

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Follow-on Biologics Have Their Own Twists and Turns. Let's Follow the Straight Path and Keep Patient Safety First. View the print ad (749 KB PDF) Follow-on Biologic Bibliography Links and references for further study. Read the bibliography

Fact Sheets

BIO Principles on Follow-On Biologics
Read the principles

Why is Patient Safety a Concern in the FOBs Debate?
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What Legal Issues are Presented by FOBs?
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What Arguments were made in Genentech's Citizen Petition on FOBs?
Read the fact sheet

How has Europe Approached FOBs (Biosimilars)?
Read the fact sheet

How do Drugs and Biologics Differ?
Read the fact sheet

BIO Studies and Press Releases

Setting the Record Straight: Generic Drug Industry Lobby 'Flat Out Wrong' About BIO Position on Follow-On Biologics (April 1, 2008)
Read the Press Release

Follow-On Biologics: New Legislation Seeks to Protect Patient Safety and Ensure Innovation (March 14, 2008)

Read BIO's press release

Read press release from bill sponsors Congresswoman Anna Eshoo and Congressman Joe Barton

Read Congresswoman Anna Eshoo's statement introducing H.R. 5629, The Pathway for Biosimilars Act

Read a summary of H.R. 5629

Read complete text of H.R. 5629

BIO letter of support for H.R. 5629 (May 9, 2008)

Leading Biotechnology Organizations Praise Effort and Express Concerns with New Follow-on Biologics Proposal (June 27, 2007)
Read the press release

BIO Calls For 14 Years of Data Exclusivity in Any Follow-On Biologics Legislation (May 3, 2007)
Read the press release
Read the complete fact sheet (63 KB PDF)
Read the one-page fact sheet (23 KB PDF)

BIO Urges Congress to Prioritize Patient Safety and Biomedical Innovation in Pathway for Follow-On Biologics (May 2)
Read the press release
Letter from patient groups to the Chairman and Ranking Member of the Subcommittee on Health (PDF)
Letter from leaders of BIO's ECS Governing Body to the Chairman and Ranking Member of the Energy and Commerce Committee (PDF)
David Schenkein, M.D., vice president of Clinical Hematology/Oncology for Genentech, will testified on behalf of BIO before the Energy and Commerce Subcommittee on Health. (PDF)

"The Difference with Biologics: The Scientific, Legal and Regulatory Challenges of Any Follow-On Biologics Scheme" (April 25, 2007)
The paper details the legal and regulatory implications of the many important differences between biologics and traditional "small molecule" drugs.
Read the White Paper (PDF)
Read the Press Release

BIO Provides Key Principles on Follow-On Biologics to Legislators (March 29, 2007)
Any Statutory Pathway for the Approval of Follow-On Biologics Must Protect Patient Safety and Preserve Incentives to Innovate
Read the press release
Letter to Senators Kennedy and Enzi (580 KB PDF)
Letter to Representatives Dingell and Barton (72 KB PDF)
Principles as attached (47 KB PDF)

BIO Urges Congress to Ensure Patient Safety and Encourage Innovation (March 26, 2007)
BIO Submits letter to Congress restating opposition to H.R. 1038.
Read Jim Greenwood's statement
Read the letter (38 KB PDF)

Congress Must Protect Patient Safety and Promote Innovation in Considering Follow-on Biologics Pathway (March 8, 2007)
BIO Submits Letter to Congress Detailing Concerns Regarding Clinton-Schumer Legislation
Urges Congress to Consider Any Action on Follow-Ons Independent of PDUFA
Read the press release
Read the letter (1.2 MB PDF)

BIO's Analysis of Express Scripts and PCMA Follow-on Biologics Cost Saving Studies
Read the study (84 KB PDF)
Read the press release

BIO Suggests Update to WHO's Naming Policy for Biological Products (November 13, 2006)
Read the press release
Read BIO's position statement (39 KB PDF)

Ensuring Patient Safety and Continued Innovation Must Stand As Focus Of Follow-On Biologics Debate (September 29, 2006)
Imperative To Recognize Differences Between Biologics and Other Drugs
Read the press release

Important Background Information

Follow-On Biologics: An Introduction
Power Point Slides (183 KB PDF)

The Effect on Federal Spending of Legislation Creating a Regulatory Framework for Follow-on Biologics: Key Issues and Assumptions (August 2007)
Authors: Henry Grabowski, Iain Cockburn, Genia Long, Richard Mortimer, Scott Johnson
Read the White Paper (244 KB)

Hearing on “Follow-On Biologics”
Senate Committee on Health, Education, Labor, and Pensions (March 8, 2007)
Hearing Testimony and Webcast

FDA's Follow-on Biologics Page:
Regulatory and Scientific Issues Related to Developing Follow-On Protein Products
Learn more

European Medicines Agency (EMEA) Biosimilar Guidelines
Scientific Guidelines for Human Medicinal Products
Read their Biologicals Guidelines

Hearing on "The Law of Biologic Medicine"
Senate Judiciary Committee (June 23, 2004)
Hearing Testimony and Webcast

BIO's Follow-on Biologics Archive
Read more

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