Insulin Gains New Pathway to Increased Competition

Statement From: Statement Author Leadership Role Principal Deputy Commissioner - Office of the Commissioner Amy Abernethy MD, PhD. Leadership Role Director - Center for Drug Evaluation and Research Janet Woodcock M.D. Today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. The availability of sa...