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ASBM Advisory Board Members Urge FDA to Adopt Unique Names for Biosimilars

Wednesday, June 13th, 2012

Physician’s Panel Says Patient Safety Undermined without Unique Names

WASHINGTON – In response to a recent letter by the National Coalition on Health Care on the issue of biosimilar naming, the Alliance for Safe Biologic Medicines (ASBM) and members of its National Advisory Board urge the U.S. Food and Drug Administration (FDA) to implement distinguishable nonproprietary names for all biosimilar products in order to ensure accurate prescribing, safe distribution and substitution and timely reporting of adverse events.

Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines released the following statement:

“ASBM recently convened a sub-group of our National Advisory Board to discuss some of the unique challenges physicians will face as the U.S. marketplace becomes more complicated with the arrival of biosimilars. Biologics can be highly sensitive to the manufacturing process and identifying specifically which product a patient received is essential to identifying any product-related adverse events. As practicing physicians we all agree that distinct names are a critical component of a strong track and trace system that will help ensure patient safety. While we believe that the National Coalition on Health Care is committed to patient safety, we are concerned that their recommended approach of using the same International Nonproprietary Names (INN) would lead to a weakened pharmacovigilance system that could put patients at risk.

“Uniquely identifiable names will more effectively enable tracking and tracing and product identification in the case of an adverse event than if a biologic product and its biosimilar versions from different manufacturers all share identical names.

“At the end of the day, distinguishable nonproprietary names are but one of a number of measures to protect patients and ensure that product problems do not become class problems due to a lack of traceability. Today, regulators in Thailand are struggling to attribute an increase in adverse events associated with a biologic medicine and are requiring re-evaluation of all approved dossiers and implementing new patient registries to reactively evaluate rates of occurrence. Here in the U.S., we have the opportunity to learn from foreign experiences and set sound policy. Along with distinguishable names, mandating transparent labels, distinctive packaging and discrete product codes for biologics and biosimilars will also enable more effective pharmacogivilance.”

Dr. Robert Yapundich, a practicing neurologist, who also participated in the sub-group discussion, added to Dr. Dolinar’s concerns.

“As a treating physician, my primary concern is the well-being of my patients and there is compelling evidence that distinct nonproprietary names for biosimilars are necessary for patient safety. In fact, distinguishable names may in some cases be the only means to trace an adverse event back to the product that caused it, especially among patients and physicians without access to a product code or lot number. Ultimately the physician community is confident that the FDA will require unique nonproprietary names in the interest of patient safety.”

To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email media@safebiologics.org.

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. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond. Visit us at www.safebiologics.org.

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