BOSTON, Mass. – Speaking at the 49th Annual Drug Information Association (DIA) Conference, Dr. Richard Dolinar, chairman of The Alliance for Safe Biologic Medicines (ASBM), presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dr. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality and consistency are vital for ensuring a steady and safe supply of biologic medicines for patients.

“It is important for prescribers to understand how policies toward biologic drugs are taking shape and why manufacturing quality remains key to supply,” said Dr. Dolinar, a practicing endocrinologist. “Biologics are incredibly complex and as such not yet well understood, but we can avoid the pitfalls of the past by developing sound policy that centers on patient safety and efficacy.”

“Prescribers have an important role to play in terms of offering a clinical, evidence-based perspective on the safe use of biologics,” said Dr. Dolinar. “As a prescriber, I will pay attention to a manufacturer’s track record on quality and constancy of supply to ensure the best outcomes for my patients.”

In his presentation, Dr. Dolinar discussed the findings of a 2011 Food and Drug Administration (FDA) analysis that attributed a majority of drug shortages to manufacturing problems and quality concerns. Of those shortages, 89 percent occurred among sterile injectables, which share a delivery mechanism with biologics.

He also referenced a 2013 study by University of Pennsylvania researchers, which found that 83 percent of oncologists had experienced drug shortages in the past six months. Of those physicians, 79 percent had to switch patients to different medicines, and 43 percent had to delay treatments.

“Shortages that force physicians to postpone treatment or switch patients to less effective medication are a serious risk to patient health,” said Dr. Dolinar.

Dr. Dolinar also stressed that giving biosimilars distinct non-proprietary names different from their reference biologic is essential for holding manufacturers responsible for their products, accurately attributing adverse events, and maintaining a safe biotech drug supply.

“Manufacturing transparency is vital. We cannot confuse problems with one biosimilar product with complications from another,” Dr. Dolinar concluded. “We must be able to distinctly identify products in order to partner effectively with patients, manufacturers, and FDA to keep the biotech drug supply safe and effectively treat disease.”

The DIA 2013 49th Annual Meeting is the largest global multidisciplinary event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products. The DIA Annual Meeting covers all aspects of the life sciences industries offering more than 250 sessions on hot topics and is key for individuals in the industry.

See Dolinar’s presentation.

See DIA conference highlights here.


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