November 8, 2021
On October 21st, ASBM’s Philip Schneider participated in the World Drug Safety Congress USA 2021, held in Boston, MA. Dr. Schneider led a panel discussion on improving pharmacovigilance programs globally. Panelists were in general agreement that there is a greater need for improving the quality of adverse drug event reports, particularly in developed countries. Improvement of […]
November 2, 2021
In October, the FDA finalized its guidance document “Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry”, addressing additional questions and answers related to biosimilar development. This is the second such revision to the guidance. The update added five questions, including: Sponsor responsibilities related to pediatric assessments for proposed biosimilar products The […]
November 1, 2021
Today, November 1st, is the First National Biologic Coordinator’s Day. Starting and staying on a prescribed biologic treatment can be a complex process for patients—but it doesn’t always have to be. Thanks to the tireless work of BIOLOGIC COORDINATORS, patients are able to access their prescribed biologic treatments. A biologic coordinator is a key member of […]
October 25, 2021
On October 19th, ASBM participated in the World Health Organization’s 73rd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the seventeenth INN Consultation in which ASBM has participated. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. While the discussions at the […]
September 30, 2021
On September 28th, ASBM Advisory Board Chair Philip Schneider presented an online Continuing Education (CE) course entitled the “The State of the Biosimilars Market in 2021”. The course was presented in conjunction with Long Island University College of Pharmacy and is the third in the series “Biosimilars: What Pharmacists Need to Know”. The series is accredited by the […]
September 30, 2021
On September 28th, ASBM Advisory Board Chair Philip Schneider presented an online Continuing Education (CE) course entitled the “The State of the Biosimilars Market in 2021”. The course was presented in conjunction with Long Island University College of Pharmacy and is the third in the series “Biosimilars: What Pharmacists Need to Know”. The series is accredited by the […]
September 30, 2021
During the months of September and October, three op-eds by ASBM Executive Director Michael Reilly ran in numerous Canadian papers throughout Quebec, New Brunswick, and Ontario. Quebec and New Brunswick recently announced they would be adopting forced biosimilar switching policies. Ontario has considered, but not yet implemented such a move. Read the Quebec op-ed here (French) Read the New […]
September 30, 2021
On September 30th, the Generics and Biosimilars Initiative published GaBI Journal, Volume 10, 2021, Issue 3, containing a new whitepaper by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The paper is entitled “A Critical Review of Substitution Policy for Biosimilars in Canada” and highlights the stark contrast between the forced-substitution policies recently enacted by some Canadian provinces and the pro-competition policies […]
September 30, 2021
On September 30th, the Generics and Biosimilars Initiative published GaBI Journal, Volume 10, 2021, Issue 3, containing a new whitepaper by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The paper is entitled “A Critical Review of Substitution Policy for Biosimilars in Canada” and highlights the stark contrast between the forced-substitution policies recently enacted by some Canadian provinces and the pro-competition policies […]
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 […]
