ASBM Comments Cited in Decision to Remove Biologic Medicines from NIOSH Hazardous Drugs List 

August 10, 2020

On July 30th, ASBM submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH’s) proposed Hazardous Drugs List additions for 2020. (The original due date for comments had been June 30th, but the comment period was extended to July 30th.) When the comment period was initially announced, several biologic medicines had been proposed- […]

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ASBM Comments Cited in Decision to Remove Biologic Medicines from NIOSH Hazardous Drugs List

August 6, 2020

ASBM Comments Cited in Decision to Remove Biologic Medicines from NIOSH Hazardous Drugs List    On July 30th, ASBM submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH’s) proposed Hazardous Drugs List additions for 2020. (The original due date for comments had been June 30th, but the comment period was extended to […]

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Biosimilar Working Group Sends Letter to Manitoba Opposing Forced Substitution

June 18, 2020

In a letter dated June 18, the Canada-based Biosimilar Working Group (BWG) urged the Canadian province of Manitoba to reject the forced-substitution policies some provinces are implementing to increase biosimilar uptake. The letter was addressed to Cameron Friesen, Manitoba’s Minister of Health, Seniors, and Active Living. From the letter:   We have concerns regarding implementation of […]

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ASBM Exhibits at Three Virtual Conferences in June

June 15, 2020

During the month of June, ASBM will be participating in three virtual conferences. We encourage all our members to visit the websites of these virtual conferences.   EULAR E-Congress (From June 3) ASBM will present a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars”. Data is drawn from ASBM’s 2019 survey of Rheumatologists in France, Germany, Italy, […]

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ASBM Surveys Included in Systemic Review of Physician Biosimilar Perspectives

June 1, 2020

On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies […]

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ASBM Surveys of Physician Perspectives on Biosimilars Included in Systemic Review

May 13, 2020

On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies […]

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Gastroenterologists: More Evidence Needed Before Non-Medical Switching of IBD Patients

May 5, 2020

On April 27th, the journal Digesitve Diseases and Sciences published a editorial by Frank I. Scott, MD entitled “Infliximab Versus Biosimilars for IBD: Is It Better to Fight Than Switch?. Dr. Scott heads the Crohn’s and Colitis Center, Division of Gastroenterology and Hepatology, Department of Medicine, at the University of Colorado. In the editorial, Dr. Scott discusses a study appearing in the April issue […]

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ASBM Presents on Need for International Harmonization of Biologic Nomenclature at WHO 70th INN Consultation

April 23, 2020

On April 21st, ASBM presented to the World Health Organization’s (WHO’s) 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fourteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. Due to coronavirus-related travel restrictions in […]

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ASBM Submits Comments on FDA Draft Guidance for Communications Regarding Biosimilars

April 15, 2020

On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific […]

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ASBM Whitepaper: Lessons from European Biosimilar Markets

March 25, 2020

On March 25th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published a whitepaper entitled Policy recommendations for a sustainable biosimilars market: lessons from Europe. The paper was authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The biosimilar market in Europe is the largest in the world, representing approximately 60% of […]

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