September 27, 2018
On September 21st, 2018 ASBM submitted comments to FDA as a follow-up to September 4th Public Hearing “Facilitating Competition and Innovation in the Biological Products Marketplace”, at which three ASBM Chairs, and several Steering Committee members testified. The purpose of the hearing and the request for comments, is to seek input on how the FDA can achieve the following goals: […]
February 8, 2018
For Immediate Release Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards Arlington, VA (February 8, 2018) The Alliance for Safe Biologic Medicines (ASBM) announced today that it has developed a web-based tool for the naming of biologic medicines to quickly ensure compliance with naming standards set forth by the FDA […]
October 17, 2017
For Immediate Release ~National survey reveals physician attitudes on key policy issues related to originator biologics and biosimilars ~ Ottawa, Ontario (November 22, 2017) A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. Survey results also […]
October 17, 2017
For Immediate Release ~National survey reveals physician attitudes on key policy issues related to originator biologics and biosimilars ~ Ottawa, Ontario (November 22, 2017) A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. Survey results also […]
September 7, 2017
ARLINGTON, VA- In a meeting today, the Alliance for Safe Biologic Medicines (ASBM) introduced rheumatologist Madelaine Feldman, MD, FACR as the organizations incoming chairperson. Dr. Feldman succeeds outgoing chair Harry L. Gewanter, MD, FAAP, FACR, whose 3-year term expired August 31, 2017. Dr. Feldman will be the third chairperson since ASBM was founded in 2010. […]
September 7, 2017
ARLINGTON, VA- In a meeting today, the Alliance for Safe Biologic Medicines (ASBM) introduced rheumatologist Madelaine Feldman, MD, FACR as the organizations incoming chairperson. Dr. Feldman succeeds outgoing chair Harry L. Gewanter, MD, FAAP, FACR, whose 3-year term expired August 31, 2017. Dr. Feldman will be the third chairperson since ASBM was founded in 2010. […]
May 19, 2017
On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product. The comments may be read in their entirety below, or are available here as a PDF. May 22, 2017 Division of Dockets Management (HFA-305)here. Food and Drug Administration Department of Health and Human Services […]
February 16, 2017
A leading authority on international biosimilar medicines policies today released new research that identifies key areas to improve Australian physicians’ confidence in prescribing biosimilar medicines. The Alliance for Safe Biologic Medicines (ASBM), a non-profit organization, surveyed 160 Australian physicians who prescribe biologics from seven therapeutic specialties with respect to their beliefs and attitudes […]
January 13, 2017
FOR IMMEDIATE RELEASE ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products (Issued January 12, 2017) ARLINGTON, Va. – The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming: We commend the FDA for its continued leadership in emphasizing the importance […]
January 13, 2017
FOR IMMEDIATE RELEASE ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products (Issued January 12, 2017) ARLINGTON, Va. – The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming: We commend the FDA for its continued leadership in emphasizing the importance […]
