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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
On August 22nd, the Journal of the Generics and Biosimilars Journal (GaBI Journal) published 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 […]
On August 26th, ASBM’s Advisory Board Chair Philip Schneider gave a series of presentations at a Biosimilars Forum hosted by the Malta Medicines Authority in Valetta, Malta. Dr. Schneider provided an extensive overview of multiple topics related to biosimilars, including: Biosimilars: General Concepts (20 min) View here Biologic Nomenclature and the Importance of Non-proprietary Names […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Biologic medicines are used to treat millions of patients with serious illnesses like cancer, arthritis, and psoriasis. The patents for many biologic therapies are expiring over the coming years, and biosimilars will be entering the marketplace. Regulatory authorities around the world have put policies in place to ensure that biosimilars have been appropriately tested, and are safe and effective for patients.
The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups and individuals—from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
