ASBM Submits Comments on FDA Interchangeability Guidance

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On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product.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 […]

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New research reveals how Australian physician confidence in prescribing biosimilars could be bolstered

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 […]

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ASBM Statement on FDA’s Final Naming Guidance

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 […]

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ASBM Latin American Chapter Joins Biosimilars Forum in Brazil

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 […]

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70 Stakeholder Groups Call on the FDA, Urging Distinguishable, Meaningful Suffixes for Biosimilars

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 […]

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ASBM Releases Pharmacist Survey; Findings Show Strong Support for Distinguishable Names for Biologics and Need for Transparency in Labeling

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 […]

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ASBM Presents at 61st WHO Naming Consultation

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 […]

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ASBM Statement on FDA Draft Guidance: “Nonproprietary Naming of Biological Products”

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 […]

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Latin American Physicians Support Distinguishable Biosimilar Naming, Survey Finds

June 18, 2015

The Alliance for Safe Biologic Medicines (ASBM) today presented at the 51st Annual Meeting of the Drug Information Association (DIA). Physician data regarding biosimilars was shared from five surveys and eleven countries, including for the first time the results of ASBM’s recent survey of Latin American physicians.

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ASBM Presents at 60th WHO Naming Meeting

April 14, 2015

Geneva, Switzerland – The Alliance for Safe Biologic Medicines (ASBM) Chairman Harry Gewanter, M.D. and International Advisory Board Chair and pharmacist, Philip J. Schneider, M.S., F.A.S.H.P., jointly presented at the World Health Organization’s (WHO) 60th International Nonproprietary Naming Stakeholders Session on Monday, April 13, 2015. The duo provided perspectives from both a physician and pharmacist […]

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