On October 23rd, ASBM Advisory Board Chair, Philip Schneider, MS, FASHP and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented before the 67th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the eleventh INN Consultation at which ASBM has presented since 2013. While the discussions […]
Regulators, Physicians, Patients to WHO: A Harmonized Biologic Naming Protocol is Important to Patient Safety; Please Act Now A whitepaper released today by the Alliance for Safe Biologic Medicines calls on the World Health Organization (WHO) to implement a harmonized naming protocol for biologic medicines to help keep patients safe. Names – of products, people, […]
Three physicians and two patient advocates discuss their concerns with the non-medical switching of biologic medicines by third parties such as insurers or pharmacy-benefit managers (PBMs). ASBM’s Chair, Madelaine Feldman, MD FACR is joined by ASBM’s Immediate Past Chair, Harry Gewanter, MD MACR; and ASBM’s Founding Chair, Richard Dolinar, MD; to discuss physician perspectives on NMS. The patient […]
On September 30th, ASBM presented a 5-hr Continuing Education (CE) course for more than 75 New York area pharmacists. The majority of these attendees were drawn from community pharmacy practice, with a smaller number practicing in health system pharmacy. The CE course was presented in conjunction with The Arnold and Marie Schwartz College of Pharmacy […]
September 26th, ASBM held a 2-hour Continuing Education (CE) course for Rhode Island pharmacists. The course was presented in conjunction with the Rhode Island Society of Health-system Pharmacists (RISHP) and the University of Rhode Island College of Pharmacy. The course began with remarks from RISHP’s Raymond Iannuccillo, PharmD, an oncology research pharmacist with Rhode Island Hospital, who […]
The Biosimilar Working Group, a Canadian-based coalition of non-profit organizations, registered health charities, and health care advocacy coalitions, launched its website this month. The launch was announced in conjunction with the Group’s September meeting in Toronto, ON. The Biosimilars Working Group is dedicated to ensuring that good outcomes for patients are at the centre of health […]
On September 4th, 2018, the U.S. Food and Drug Administration (FDA) held a hearing on the Biosimilar Action Plan announced by FDA Commissioner Scott Gottlieb in July. The action plan addressed 4 key areas intended to improve biosimilar competition: Improving the efficiency of the biosimilar and interchangeable product development and approval process Maximizing scientific and regulatory clarity […]
On July 12, in Washington, DC the Alliance for Safe Biologic Medicines (ASBM) hosted the second in a series of meetings to discuss the global harmonization of nomenclature for biologic and biosimilar medicines. Representatives from the World Health Organization, the U.S. Food and Drug Administration (FDA), Health Canada, the United States Pharmacopeia (USP), and the American […]
On April 11th in Washington DC, nearly 25 individuals gathered to be part of an exclusive roundtable to discuss a global approach for naming harmonization of biologic medicines. Representatives from the U.S. Food and Drug Administration, Health Canada, physician and pharmacist associations, and patient advocacy organizations convened to explore the feasibility of this endeavor and […]
For Immediate Release Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards Arlington, VA (February 8, 2018) The Alliance for Safe Biologic Medicines (ASBM) announced today that it has developed a web-based tool for the naming of biologic medicines to quickly ensure compliance with naming standards set forth by the FDA […]
On November 2nd, 2018, the GaBI Journal published an article by Former FDA Associate Commissioner, Peter J. Pitts and ASBM Executive Director Michael Reilly, entitled “Medicines regulation in the Middle East and the importance of the World Health Organization’s INN proposal of Biological Qualifier”. The article examines the safety and pharmacovigilance benefits the WHO’s BQ proposal would […]
On October 23rd, ASBM Advisory Board Chair, Philip Schneider, MS, FASHP and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented before the 67th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the eleventh INN Consultation at which ASBM has presented since 2013. While the discussions […]
Regulators, Physicians, Patients to WHO: A Harmonized Biologic Naming Protocol is Important to Patient Safety; Please Act Now A whitepaper released today by the Alliance for Safe Biologic Medicines calls on the World Health Organization (WHO) to implement a harmonized naming protocol for biologic medicines to help keep patients safe. Names – of products, people, […]
Three physicians and two patient advocates discuss their concerns with the non-medical switching of biologic medicines by third parties such as insurers or pharmacy-benefit managers (PBMs). ASBM’s Chair, Madelaine Feldman, MD FACR is joined by ASBM’s Immediate Past Chair, Harry Gewanter, MD MACR; and ASBM’s Founding Chair, Richard Dolinar, MD; to discuss physician perspectives on NMS. The patient […]
On September 30th, ASBM presented a 5-hr Continuing Education (CE) course for more than 75 New York area pharmacists. The majority of these attendees were drawn from community pharmacy practice, with a smaller number practicing in health system pharmacy. The CE course was presented in conjunction with The Arnold and Marie Schwartz College of Pharmacy […]
September 26th, ASBM held a 2-hour Continuing Education (CE) course for Rhode Island pharmacists. The course was presented in conjunction with the Rhode Island Society of Health-system Pharmacists (RISHP) and the University of Rhode Island College of Pharmacy. The course began with remarks from RISHP’s Raymond Iannuccillo, PharmD, an oncology research pharmacist with Rhode Island Hospital, who […]
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.
