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
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 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 […]
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 15, 2021
From November 9th-11th, ASBM participated in the World Biosimilar Congress 2021 Europe, held in Basel, Switzerland. ASBM was represented at the conference by Advisory Board Chair Philip Schneider and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association (GCCA). The theme of the three-day meeting was “Celebrating 15 years of Biosimilars […]
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 […]
