Letters to FDA Praise Use of Distinguishable Biosimilar Naming, Urge Greater Label Transparency
May 13, 2015
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 […]