Alliance for Safe Biologic Medicines (03/23/2015)

A recent survey investigated physicians' priorities with regard to biosimilar labeling. The findings, reported by the Alliance for Safe Biologic Medicines (ASBM), were presented at a meeting hosted by the American Autoimmune Related Diseases Association. The findings indicate that physicians who prescribe biologics support transparent, clear labels with data that enables prescribers to learn about and examine the medicines available to their patients. Among the 400 physicians surveyed, 90 percent said that product labels for biosimilars should clearly state they are a biosimilar. In addition, 82 percent said it is important that biosimilar labels include the analytical data developed by the biosimilar sponsor to demonstrate its analytical similarity to the reference product. At the meeting, ASBM Executive Director Michael Reilly praised the Food and Drug Administration's (FDA's) recent approval of the first biosimilar drug in the United States. "ASBM commends the FDA for their work to make biosimilars a reality for patients across the country," he said. "We believe this data provides FDA with clear guideposts for what is necessary to foster physician confidence in biosimilar medicines."

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