On April 2nd, ASBM Chair Madelaine Feldman, MD, FACR; and Advisory Board Chair, Philip Schneider, MS, FASHP presented before the 68th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the twelfth INN Consultation at which ASBM has presented since 2013. While the discussions in the Open Session at which ASBM presented are […]
From March 22nd-24th, ASBM exhibited at the Annual Meeting and Expo of the American Pharmacists Association (APhA), held in Seattle, Washington.Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians as members. ASBM was represented at its booth by Advisory Board Chair Philip Schneider, past president of the […]
On March 6th in Ottawa, Ontario, ASBM hosted the third in a series of meetings between health regulators and other stakeholders from around the globe to discuss the international harmonization of biologic nomenclature and the importance of distinguishable naming. Representatives from Health Canada, the FDA, and WHO participated. The meeting began with opening remarks by ASBM Executive Director Michael Reilly […]
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 […]
Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products May 13, 2019 Arlington, VA – US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency. Biologic medicines treat […]
On April 2nd, ASBM Chair Madelaine Feldman, MD, FACR; and Advisory Board Chair, Philip Schneider, MS, FASHP presented before the 68th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the twelfth INN Consultation at which ASBM has presented since 2013. While the discussions in the Open Session at which ASBM presented are […]
From March 22nd-24th, ASBM exhibited at the Annual Meeting and Expo of the American Pharmacists Association (APhA), held in Seattle, Washington.Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians as members. ASBM was represented at its booth by Advisory Board Chair Philip Schneider, past president of the […]
ASBM commends the decision by FDA to apply distinguishable suffixes to all biologics, including interchangeable biosimilars, going forward. FDA’s decision puts in place a protocol for a safe future, when there are many more biologics, biosimilars and interchangeable biosimilars. This policy ensures that patients and health care providers can distinguish between products when that is […]
On March 6th in Ottawa, Ontario, ASBM hosted the third in a series of meetings between health regulators and other stakeholders from around the globe to discuss the international harmonization of biologic nomenclature and the importance of distinguishable naming. Representatives from Health Canada, the FDA, and WHO participated. The meeting began with opening remarks by ASBM Executive Director Michael Reilly […]
On January 7th, ASBM Chair Madelaine Feldman, MD FACR was interviewed by the Center for Biosimilars at a forum comprised pharmacists, clinicians, and representatives from biosimilar development companies. The topic was education on biosimilars. Dr Gillian Woollett of Avalere Health moderated the discussion, which was recorded at the group’s studio in New Jersey. Clips from the interview […]
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.
