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On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product.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 […]
May 12, 2017
May 6th-9th, ASBM exhibited at Digestive Disease Week (DDW) 2017, an annual gathering of gastroenterologists, patient advocates, and drug manufacturers held in Chicago, IL. ASBM Steering Committee member Andrew Spiegel, Executive Director of Global Colon Cancer Association (GCCA), represented ASBM and GCCA in a booth shared by both groups. Mr. Spiegel discussed the importance of […]
May 12, 2017
May 6th-9th, ASBM exhibited at Digestive Disease Week (DDW) 2017, an annual gathering of gastroenterologists, patient advocates, and drug manufacturers held in Chicago, IL. ASBM Steering Committee member Andrew Spiegel, Executive Director of Global Colon Cancer Association (GCCA), represented ASBM and GCCA in a booth shared by both groups. Mr. Spiegel discussed the importance of […]
May 4, 2017
In this video, ASBM’s Advisory Board Chairman Philip Schneider, Associate Dean of the University of Arizona College of Pharmacy; and Advisory Board Member Ronald Jordan, Dean of the Chapman University School of Pharmacy discuss the role of pharmacists with respect to biosimilars.
May 2, 2017
On Friday, April 21st, the FDA approved its fifth biosimilar, Renflixis (infliximab-abda). While the second biosimilar approved for Remicade (infliximab)- the first being Inflectra (infliximab-dyyb), approved in April 2016. Renflexis is noteable as the first biosimilar to be approved without a meeting of an FDA Advisory Committee. Advisory committees provide FDA with independent opinions and […]
April 5, 2017
On April 4rd, in Geneva, Switzerland, ASBM participated in the World Health Organization’s 64rd Stakeholder Consultation on International Nonproprietary Names. ASBM has been a regular participant at the INN Consultations since 2013. ASBM’s Chairman Harry L. Gewanter, Advisory Board Chair Philip Schneider, MS, FASHP and Advisory Board Member Jeff Jones, PhD represented ASBM at this […]
March 17, 2017
On March 16th, ASBM Chairman Harry Gewanter, MD testified before the Kansas Senate Public Health and Welfare Committee in support of HB 2107 which would modify the Kansas Pharmacy Act to permit the pharmacy-level substitution of interchangeable biosimilars. ASBM’s Advisory Board Chair Philip Schneider, Associate Dean of University of Arizona College of Pharmacy testified in support […]
March 17, 2017
On March 16th, ASBM Chairman Harry Gewanter, MD testified before the Kansas Senate Public Health and Welfare Committee in support of HB 2107 which would modify the Kansas Pharmacy Act to permit the pharmacy-level substitution of interchangeable biosimilars. ASBM’s Advisory Board Chair Philip Schneider, Associate Dean of University of Arizona College of Pharmacy testified in support […]
February 21, 2017
On February 20th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified before the New Mexico Legislature in support of its biosimilar substitution bill. Dr. Schneider appeared before the House Business and Industry Committee to support and the Senate Corporations and Transportation Committee to support HB 260 and SB […]
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 […]
