Biosimilar Bibliography
Links and references for further study. Read the bibliography
What are Biosimilars?
Dr. David Targan explores the world of biosimilars, also known as follow-on biologics. Biosimilars may eventually expand patient access and provide a more affordable alternative to biologics
About Biosimilars
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.
Provisions in the Senate Health Care Bill Help Patients, Promote Innovation, Encourage Job Growth (December 24, 2009) Read the Press Release
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
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
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)
"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 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
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
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
