WASHINGTON, DC – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., added a physician’s perspective to the ongoing discussion around the naming of biologic medicines, including biosimilars.
“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dolinar. “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. Importantly, 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 which medicine was actually the root cause, and the patient will suffer.”
Dolinar stressed that unique distinguishable non-proprietary names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists. 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?” explains how biologic medicines are different from traditional chemical drugs and present unique safety concerns.
“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. “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.
ASBM called for the use of distinguishable names in a March 20th letter directly to Dr. Balocco Mattavelli, INN Program Manager at the WHO. Dr. Dolinar has also presented at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada on June 26, 2013 that Dr. Balocco attended. ASBM’s most recent statement was sent to Dr. Margaret Chang, WHO Director-General, on July 31, 2013 in advance of their upcoming 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. ASBM will also be present at that meeting to be held in Geneva on October 22, 2013.
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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.
For more information, please contact:
http://safebiologics.org/naming.php
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org
