Ottawa, ONTARIO – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada on June 26 and 27. Dolinar’s presentation added a physician’s perspective to the emerging consensus that unique product names are key to patient safety.
“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dr. Dolinar at the event. “As a physician, patient safety is paramount. I need to know as quickly as possible when and which product is associated with an unexpected outcome in order to treat my patients effectively. Identical names imply identical products, which will not be the case when biologics are made using different manufacturing processes and/or cell lines. If distinct non-proprietary names are not given to products, we may waste valuable treatment time trying to identify the root cause, and the patient will suffer.”
Dolinar’s presentation stressed that unique distinguishable INN names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists. His presentation reviewed findings in a white paper authored by ASBM entitled, “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar Therapeutics?” The paper explains how biologic medicines are different from traditional chemical drugs and present unique safety concerns. Dolinar’s presentation in Ottawa followed a presentation earlier in the week at the DIA conference in Boston and furthered the dialogue with the international community towards a consensus among stakeholders on the need for unique names for biosimilars.
“Our research in the United States clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients,” said Dolinar. “Cases have occurred wherein a prescribing physician has mistakenly omitted the distinguishing prefix, resulting in a patient receiving the wrong medication, at the wrong dose. Instituting a system of unique names for biologic medicines will achieve the common goal of enhancing access to life-changing therapies, while also protecting the safety of the patients,” Dolinar concluded.
The findings shared were also expressed in a March 20th letter directly to Dr. Balocco Mattavelli, INN Program Manager at the WHO in Geneva. Dr. Balocco joined Dr. Dolinar and ASBM Executive Director Michael Reilly, along with a hospital pharmacist, and the Chair of the International Alliance for Patient Organizations (IAPO) at the Ottawa forum.
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About the Alliance for Safe Biologic Medicines:
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.
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Alliance for Safe Biologic Medicines