Chairman Dr. Dolinar Speaks at Top Biosimilars Industry Conference

Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, presented at the CBI’s 7th Summit on Biosimilars and follow-on Biologics on “Track and Trace – The Need for Pharmacovigilance with Biologics”.

The Washington, D.C. event was attended by biologic and biosimilar manufacturers and others in the scientific community. It followed on the heels of the U.S. Food and Drug Administration’s recently released draft guidance on biosimilar medicines, which outlines the steps for biosimilar manufacturers to market their products in the United States. The Agency has yet to outline naming policies for biosimilars.

In his presentation, Dr. Dolinar addressed why track and trace is important in the context of biosimilars and concrete steps to improve patient safety:

“As a practicing physician who has primary responsibility for the health and welfare of my patients, I believe that unique names are a fundamental safety issue. Biologics and biosimilars are unlike chemical drugs as they are made from living cells and any change in environment, raw materials, or manufacturing process can alter the final medicine. Unique names facilitate effective tracking and tracing and actually enable physicians to leverage both their knowledge and experience with products to make treatment choices that are appropriate for a particular patient. Such a track and trace system would also help minimize risk to patients through accurate product attribution of any adverse events.

“It would only take one catastrophe to end the U.S. biosimilar program. That’s why effective implementation of the biosimilars pathway is dependent upon a strong track and trace system that puts patients first and on the knowledge of those on the frontlines of healthcare – the doctor and patient.”


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.