December 12, 2021
The World Health Organization recently published the Executive Summary of its 73rd Consultation on International Nonproprietary Names, at which ASBM presented on October 19, 2021. From the Executive Summary: Objections to the use of distinct non-proprietary names for biosimilars quote that they may imply inferiority, that they may undermine confidence in their use and may hinder uptake. […]
December 8, 2021
On November 15th, ASBM Chairman Ralph McKibbin, MD moderated a panel discussion at the Digestive Disease National Coalition’s Fall policy-setting forum. The Fall Forum ran from November 15th-19th and gathered together policymakers, caregivers, and patients to discuss the latest developments in digestive disease policy. The webinar included an overview of DDNC funding priorities, presentations from DDNC member […]
December 8, 2021
House Bill Would Distort Treatment Decisions, Undermine Physician-Patient Relationship On December 2nd, ASBM sent a letter to House leaders reiterating our opposition. The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar. The bill calls for […]
December 2, 2021
On November 17th, ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR testified at a public hearing of the Congressional Oversight Committee. Entitled “Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets”, the hearing examined the role of PBMs in contributing to higher drug prices. From Dr. Feldman’s testimony: The out-of-pocket costs for these miraculous RA medications […]
November 8, 2021
House Bill Would Distort Treatment Decisions, Undermine Physician-Patient Relationship The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar. The bill calls for a “temporary increase in Medicare Part B payments for certain biosimilars,” […]
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 […]
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 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
ASBM Welcomes Ralph McKibbin, MD as Chairman In a Full Member Call September 9th, 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 is the fourth chairman since ASBM was […]
