January 13, 2017
FOR IMMEDIATE RELEASE ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products (Issued January 12, 2017) ARLINGTON, Va. – The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming: We commend the FDA for its continued leadership in emphasizing the importance […]
January 7, 2017
newsletter | January 2017 issue 54 Who We Are The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It […]
November 18, 2016
Philip J. Schneider, MS FASHP Associate Dean, University of Arizona College of Pharmacy ASBM Advisory Board Chair This past weekend it was my honor to participate in a continuing education course for 100 New York pharmacists on the topic of biologic medicines and biosimilars, including safety and regulatory considerations which affect pharmacy practice. The 5-hour […]
November 7, 2016
newsletter | November 2016 issue 53 Who We Are The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It […]
November 7, 2016
Harry L. Gewanter, MD, FAAP, FACR Chairman, ASBM Since becoming involved with ASBM on the Medical Advisory Board and, more recently, as Chairman, I’ve learned a great deal about biosimilars. Being a pediatrician, I have found that analogies are an extraordinarily helpful means to explain complex issues. This video has proven to be an […]
October 20, 2016
On October 20th, representatives from the patient, physician, and pharmacist communities joined manufacturers of innovator biologics and biosimilars to discuss reauthorization of the Biosimilars User Fee Act (BsUFA). BsUFA is a five-year agreement between FDA and stakeholders that finances the FDA’s review of biosimilars through fees paid by biosimilar sponsors. It is set to expire […]
October 19, 2016
On October 18th, in Geneva, Switzerland, ASBM President Doug Badger and Advisory Board Chair Philip Schneider, MS, FASHP participated in the World Health Organization’s 63rd Stakeholder Consultation on International Nonproprietary Names. The subject of the INN meeting is the continued development of the INN Programme’s Biologic Qualifier (BQ) proposal. The is a modification to the INN system designed […]
October 12, 2016
On October 12th, in Toronto, Ontario, ASBM participated in an educational webinar for the Ontario Hospital Association, which represents 150 hospitals in the Canadian province. ASBM Executive Director Michael Reilly participated on a panel with Canadian physicians, patients, and industry representatives. Around 100 attendees were present. Mr. Reilly discussed the state of biosimilar uptake […]
September 28, 2016
SÁO PAULO, BRAZIL- The Latin American Chapter of the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) today participated in a biologics and biosimilars forum in Sáo Paulo, Brazil. The chapter is comprised of eight patient organizations representing a variety of disease groups including multiple forms of cancer, hepatitis, and […]
September 21, 2016
By Michael Reilly, Executive Director, ASBM To date, the FDA has approved three biosimilars. The first, Zarxio (filgrastim-sndz), used a meaningful, memorable suffix based on the manufacturers name (Sandoz). The second two use the random suffixes “-dyyb” and “-szzs” which mean, well, nothing. ASBM’s surveys have shown that physicians (78%) and pharmacists (85%) support memorable […]
