October 17, 2017
Ottawa, ON – Today, the Alliance for Safe Biologic Medicines (ASBM) released results from a survey that found that Canadian physicians overwhelmingly support Health Canada implementation of distinguishable names. Survey results also found that Canadian physicians are open to substituting biosimilars for non-medical reasons, only when they are the ultimate decision-maker for their patient, not […]
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On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product.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 […]
September 28, 2016
SÁO PAULO, BRAZIL- The Latin American Chapter of the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) today participated in a biologics and biosimilars forum in Sáo Paulo, Brazil. The chapter is comprised of eight patient organizations representing a variety of disease groups including multiple forms of cancer, hepatitis, and […]
May 11, 2016
WASHINGTON, DC—In a letter to the FDA this week, a 70-group coalition of healthcare stakeholders including patient and provider organizations and others urged the use of distinguishable, meaningful suffixes for biosimilars. The letter to Leah Christl, Ph.D., FDA’s associate director for therapeutic biologics, comes on the heels of FDA’s departure from a meaningful to random […]
October 14, 2015
For Immediate Release: October 13, 2015 WASHINGTON, DC – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a survey of 401 U.S. pharmacists showing strong support for distinguishable names for biologics and biosimilars and the need for more transparency in labeling. “This survey reinforces what ASBM has been hearing from pharmacists […]
October 13, 2015
Geneva, Switzerland – On October 13th, the Alliance for Safe Biologic Medicines (ASBM) presented before the World Health Organization’s (WHO’s) 61st Consultation on International Nonproprietary Names (INN). ASBM Chairman Harry L Gewanter, MD presented physician perspectives on biosimilar naming gathered from prescribers in eleven countries. This included data from ASBM’s recent survey of Latin American […]
September 1, 2015
The Alliance for Safe Biologic Medicines commends the FDA for its leadership on biosimilars by releasing guidance that recognizes the need for all biologic medicines, including biosimilars, to be clearly distinguishable from one another. This clarity will aid in accurate product identification during prescribing, dispensing, and pharmacovigilance. Distinguishable naming is particularly important with the arrival […]
