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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ASBM Meets with Health Canada, FDA, WHO on Biologic Nomenclature Harmonization

March 7, 2019

On March 6th in Ottawa, Ontario, ASBM hosted the third in a series of meetings between health regulators and other stakeholders from around the globe to discuss the international harmonization of biologic nomenclature and the importance of distinguishable naming. Representatives from Health Canada, the FDA, and WHO participated.  The meeting began with opening remarks by ASBM Executive Director Michael Reilly […]

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ASBM Chair Discusses Interchangeability, Need for Education

March 2, 2019

On January 7th, ASBM Chair Madelaine Feldman, MD FACR was interviewed by the Center for Biosimilars at a forum comprised pharmacists, clinicians, and representatives from biosimilar development companies. The topic was education on biosimilars. Dr Gillian Woollett of Avalere Health moderated the discussion, which was recorded at the group’s studio in New Jersey. Clips from the interview […]

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ASBM Chair Discusses Interchangeability, Need for Education

March 2, 2019

On January 7th, ASBM Chair Madelaine Feldman, MD FACR was interviewed by the Center for Biosimilars at a forum comprised pharmacists, clinicians, and representatives from biosimilar development companies. The topic was education on biosimilars. Dr Gillian Woollett of Avalere Health moderated the discussion, which was recorded at the group’s studio in New Jersey. Clips from the interview […]

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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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ASBM Exhibits at the ASHP Midyear Meeting

December 12, 2018

December 3rd-5th, ASBM exhibited at the Midyear Meeting of the American Society of Health-system Pharmacists (ASHP) in Anaheim, CA. The meeting was attended by more than 25,000 pharmacists and is widely known in the pharmacy community as the largest professional gathering of pharmacists in the world. ASBM was represented at the Midyear Meeting by its […]

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GaBI Journal: Benefits of WHO’s BQ Proposal to Middle Eastern Countries; co-authored by ASBM’s Michael Reilly

November 14, 2018

On November 2nd, 2018, the GaBI Journal published an article by Former FDA Associate Commissioner, Peter J. Pitts and ASBM Executive Director Michael Reilly, entitled “Medicines regulation in the Middle East and the importance of the World Health Organization’s INN proposal of Biological Qualifier”. The article examines the safety and pharmacovigilance benefits the WHO’s BQ proposal would […]

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ASBM Presents at 67th WHO INN Consultation

November 6, 2018

On October 23rd, ASBM Advisory Board Chair, Philip Schneider, MS, FASHP and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented before the 67th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the eleventh INN Consultation at which ASBM has presented since 2013.  While the discussions […]

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