ASBM Submits Comments to FDA on Biosimilars

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: […]

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Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards

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 […]

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Alliance for Safe Biologic Medicines Releases 2017 Canadian Prescriber Survey

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 […]

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ASBM Welcomes Madelaine Feldman as Chair

September 7, 2017

ARLINGTON, VA- In a meeting today, the Alliance for Safe Biologic Medicines (ASBM) introduced rheumatologist Madelaine Feldman, MD, FACR as the organization’s 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. […]

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On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product.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