Alliance for Safe Biologic Medicines Chairman Urges FDA to Ensure that Patient Safety is the Cornerstone of Biosimilar Pathway

May 16, 2012

Prepared Remarks Identify Clinical Trials, Global Supply Chain, Unique Naming, Clear Packaging Information, and Interchangeability as Areas for Careful Consideration WASHINGTON — Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (Alliance) outlined five areas of concern that the U.S. Food and Drug Administration (FDA) should resolve before they allow biosimilar medications on […]

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Alliance for Safe Biologic Medicines Welcomes FDA Biosimilars Draft Guidance, Urges Cautious Approach to Ensure Patient Safety

April 16, 2012

Comments to FDA Stress Need for Clinical Trials, Restraint for Interchangeability Designations, and Unique Names for Biosimilar Products Washington, D.C. — In response to the U.S. Food and Drug Administration’s (FDA) draft guidance on the approval of biosimilar medicines, the Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA that outlined recommended steps […]

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Alliance for Safe Biologic Medicines Calls for Improved Pharmacovigilance

March 6, 2012

Chairman Dr. Dolinar Speaks at Top Biosimilars Industry Conference Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, presented at the CBI’s 7th Summit on Biosimilars and follow-on Biologics on “Track and Trace – The Need for Pharmacovigilance with Biologics”. […]

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Patient Safety Must Guide Regulatory Decisions

February 27, 2012

Capitol Hill Biosimilars Policy Forum Discusses Recent FDA Guidances Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, partnered with Bloomberg Government to host “Biosimilars Policy Forum: Keeping Patients Safe” on February 27, 2012. The event followed the release of […]

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Alliance for Safe Biologic Medicines Welcomes Biosimilars Pathway

February 9, 2012

Urges FDA to put patient safety first as draft guidance finalized WASHINGTON, Feb. 9, 2012  — In response to the release of the U.S. Food and Drug Administration’s long-awaited draft guidance on the approval of biosimilar medicines in the United States, Dr. Dolinar, Chairman of the Alliance for Safe Biologic Medicines (ASBM) issued the following […]

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Alliance for Safe Biologic Medicines Welcomes First Steps Towards Patient-Centered Biosimilars Pathway

December 9, 2011

Robust clinical trials will ensure that biosimlars are safe and effective for patients Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, welcomes the first steps from the U.S. Food and Drug Administration (FDA) to bring biosimilars on the market […]

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