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Unique Names for Biosimilar Products Washington, D.C. — In response to the U.S. Food and Drug Administration’s (FDA) draft guidance on the approval of biosimilar medicines, the Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA that outlined recommended steps […]

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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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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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Urges FDA to put patient safety first as draft guidance finalized WASHINGTON, Feb. 9, 2012  — In response to the release of the U.S. Food and Drug Administration’s long-awaited draft guidance on the approval of biosimilar medicines in the United States, Dr.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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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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