ASBM Welcomes Ralph McKibbin, MD as Chairman

September 9, 2021

ARLINGTON, VA- In a Full Member Call today the Alliance for Safe Biologic Medicines (ASBM) introduced gastroenterologist Ralph McKibbin, MD, FACP, FACG, AGAF as the organization’s incoming chairman. Dr. McKibbin began his three year term on September 1st, succeeding outgoing chair Madelaine Feldman, MD, FACR. Dr. McKibbin will be the fourth chairman since ASBM was founded in […]

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ASBM Statement Supporting Updated FDA Naming Guidance

March 12, 2019

ASBM commends the decision by FDA to apply distinguishable suffixes to all biologics, including interchangeable biosimilars, going forward. FDA’s decision puts in place a protocol for a safe future, when there are many more biologics, biosimilars and interchangeable biosimilars. This policy ensures that patients and health care providers can distinguish between products when that is […]

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Statement from ASBM Executive Director Michael Reilly in Response to a Mischaracterization of ASBM’s Work in January 10 Washington Post Article

January 16, 2019

  On January 10, 2019, the Washington Post published an article “Patients stuck in corporate fight against generic drugs.”  I spoke extensively with the author of the article and also suggested that he speak with the Chair of the Alliance for Safe Biologic Medicines (ASBM) international advisory board Dr. Philip Schneider.  Unfortunately, the article did not represent […]

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ASBM Advisory Board Chair Responds to Mischaracterization of Comments in Washington Post

January 14, 2019

by Philip Schneider, MS FASHP FFIP Advisory Board Chair, Alliance for Safe Biologic Medicines   This is to clarify an irresponsible misrepresentation by Christopher Rowland in his article “Patients Stuck In Corporate Fight Against Generic Drugs,” published in the January 9, 2019 edition of the Washington Post.   My comments that were misinterpreted in this article […]

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ASBM Advisory Board Chair Responds to Mischaracterization of Comments in Washington Post

January 14, 2019

by Philip Schneider, MS FASHP FFIP Advisory Board Chair, Alliance for Safe Biologic Medicines   This is to clarify an irresponsible misrepresentation by Christopher Rowland in his article “Patients Stuck In Corporate Fight Against Generic Drugs,” published in the January 9, 2019 edition of the Washington Post.   My comments that were misinterpreted in this article […]

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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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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 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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Physician Confidence Critical to Biosimilar Adoption, Says Panel

June 1, 2015

SAN DIEGO, CA- On May 28, 2015 a panel discussion was held that examined the perspectives of innovator companies, biosimilar manufacturers, biotechnology reporters, and the health provider community on the topic of biosimilar development and marketing. The panel was held in as part of the World Biosimilar Congress 2015. ASBM chairman Dr.Harry Gewanter provided the […]

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