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BIO is a leading advocate to create a pathway for the approval of biosimilars, medicines that are similar to, but not the same as, innovator biologics. Also known as follow-on biologics, biosimilars are not like generic pharmaceuticals which can be analyzed in a laboratory to confirm that they are exact copies of chemical drugs. Biologics are vastly more complex than traditional pharmaceuticals, and producing an exact duplicate of an existing biologic is not possible with today’s science. For this reason, the term "biogeneric" is misleading.
A well-crafted pathway for the approval of biosimilars will lower costs through increased competition, expand access to lifesaving medicines, protect patient safety and promote further biomedical innovation.
Please find below background documents including fact sheets, white papers and studies as well as BIO press statements.
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BIO Principles on Follow-On Biologics
Read the principles
Why is Patient Safety A Concern in the Biosimilars Debate?
Read the fact sheet
What Legal Issues are Presented by Biosimilars?
Read the fact sheet
What Arguments Were Made in Genentech’s Citizen Petition on Biosimilars?
Read the fact sheet
How has Europe Approached Biosimilars?
Read the fact sheet
How do Drugs and Biologics Differ?
Read the fact sheet
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BIO Urges Administration and Congressional Leaders to Reject GPhA's Request to Strike Biosimilars from Health Care Reform (October 30, 2009)
Read the Press Release
House Energy and Commerce Committee Vote Marks Another Step Forward on Pathway to Biosimilars (July 31, 2009)
Read the Press Release
BIO Testifies on Importance of Data Exclusivity and Patent Protection in Pathway for Approval of Biosimilars (July 15, 2009)
Read the Press Release
Read the testimony (1.55 MB PDF)
Read the Follow-Up Response (235 KB PDF)
Senate HELP Committee Vote Charts Right Course To Biosimilars (July 13, 2009)
Read the Press Release
New Senate Biosimilars Proposal Would Jeopardize New Medical Advancements and Cures (July 8, 2009)
Read the Press Release (68 KB PDF)
BIO Comments on White House Letter on Biosimilars (June 25, 2009)
Read the Press Release
Patients, Physicians, Researchers and Other Stakeholders Urge Senate HELP Committee to Include Pathway for Biosimilars in Health Care Reform (June 23, 2009)
Read the Letter (65 KB PDF)
AARP Biologics Study Based on Fuzzy Math, Flawed Assumptions (June 11, 2009)
Read the Press Release
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New FTC Report on Biosimilars is Fundamentally Flawed (June 10, 2009)
Read the Press Release
Read BIO’s Rebuttal
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New Senate Bill Takes Shortcuts on Path to Biosimilars (March 26, 2009)
Read the Press Release
New Bipartisan, Consensus Bill Points to Right Path to Biosimilars (March 17, 2009)
Read the Press Release
Read BIO’s Letter of Support for H.R. 1548 (133 KB PDF)
Read Council of State Bioscience Associations’ Letter of Support for H.R. 1548 (31 KB PDF)
New Biosimilars Bill "Filled With Potholes" Says BIO (March 11, 2009)
Read the Press Release
Comments on Competition Issues Involving Follow-on Biologic Drugs (December 22, 2008)
BIO’s comments to the Federal Trade Commission (1 MB PDF)
CBO Estimate of Follow-On Biologics Savings Based on Troubling Assumption, Says BIO (December 19, 2008)
Read BIO’s Press Release
Patient Safety and Incentives for Continued Innovation Must be Provided in Any Pathway for the Approval of Follow-On Biologics, BIO Tells FTC (October 1, 2008)
Read BIO’s Press Release
Read BIO’s Comments to the FTC
CBO Savings Estimate for Follow-On Biologics Underscores Need for Congress to Move Quickly to Create Pathway for Follow-On Biologics (June 25, 2008)
Read BIO's Press Release
Read Congressional Budget Office Cost Estimate
BIO provides answers to House Energy and Commerce Subcommittee on Health questionnaire on follow-on biologics (May 2, 2008)
Read BIO's cover letter (57 KB PDF)
Read BIO's answers to the questionnaire (317 KB PDF)
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
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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)
BIO Letter of Support for H.R. 1956 (August 27, 2007)
Read the letter
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 (February 22, 2007)
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
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Follow-On Biologics: An Introduction
Power Point Slides (183 KB PDF)
Data Exclusivity Period Length and Federal Government Savings from Enactment of the Biologics Price Competition and Innovation Act of 2007
Authors: Joseph Golec, John Vernon, and Ted Buckley
Read the White Paper (168 KB PDF)
FDA Response to Health Subcommittee of House Energy and Commerce Committee on Follow-On Biologics (September 18, 2008)
Read the Response (907 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 Biosimilars Archive
Read more
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