On May 6, ASBM Chairman Harry Gewanter, M.D., sent a letter to Acting FDA Commissioner Stephen Ostroff, M.D, sharing ASBM’s recent survey on labeling and raising some concerns on the same issue.
Dr. Gewanter pointed out that the labeling for the recently approved biosimilar, Zarxio, falls short with the FDA’s longstanding emphasis on transparency and that clinically important product information is absent from the label. Dr. Gewanter said it is essential that the FDA include clear, appropriate and specific product labeling so patients and their healthcare team can make the best and most informed therapeutic decisions possible.
Read the letter here.
Physicians are not the only ones concerned with biosimilar labeling. On April 23, Philip Schneider, University of Arizona College of Pharmacy professor; Ronald P. Jordan, Chapman University School of Pharmacy Dean; and Joseph J. Bova, Long Island University College of Pharmacy Director of Continuing Education – the pharmacists that participated in continuing education class with ASBM – also sent a letter to Stephen Ostroff expressing concerns. Jordan is a former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP) and in the letter the pharmacists urged the FDA to consider a requirement for more informative labeling.
Read the letter here.