October 2, 2012
WASHINGTON – On September 27, 2012 the European Medicines Agency (EMA) released a revised version of their 2008 Question and Answer (Q&A) document differentiating the regulatory standards for biosimilar medicines from the standards used to support generic chemical medicines. ASBM Chairman Richard Dolinar, MD, released the following statement in recognition of the importance of that […]
October 1, 2012
PHOENIX – The Alliance for Safe Biologic Medicines (ASBM), the International Cancer Advocacy Network (ICAN) and Arizona Bio hosted “Biosimilars Policy Forum: Ensuring Patient Safety” in Phoenix, AZ. The forum provided an opportunity for robust discussion of the complex challenges associated with ensuring the safety of all biologic medicines, as well as the benefits that […]
September 17, 2012
WASHINGTON – The Alliance for Safe Biologic Medicines (ASBM) today announced the results of a new survey on physician opinions relating to biologics and biosimilars. ASBM Chairman, Dr. Richard O. Dolinar, presented key findings during the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C., where he urged the FDA to make patient-safety the […]
June 13, 2012
Physician’s Panel Says Patient Safety Undermined without Unique Names WASHINGTON – In response to a recent letter by the National Coalition on Health Care on the issue of biosimilar naming, the Alliance for Safe Biologic Medicines (ASBM) and members of its National Advisory Board urge the U.S. Food and Drug Administration (FDA) to implement distinguishable […]
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 […]
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Unique Names for Biosimilar Products Washington, D.C. — In response to the U.S. Food and Drug Administration’s (FDA) draft guidance on the approval of biosimilar medicines, the Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA that outlined recommended steps […]
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”. […]
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 […]
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 […]
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 […]
