FDA Approves Another Interchangeable Biosimilar Drug

By Kevin E. Noonan — On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug. That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained biosimilar approval on August 25, 2017. In this recent approval, the FDA determined that Cyltezo is interchangeable with AbbVie’s Humira (adalimumab), its reference product. Cyltezo is the first monoclonal antibody biosimilar to be deemed an interchangeable biosimilar drug product. One of the benefits of interchangeability is that physicians’ input (and approval) is not needed for substitution, which can be implemented at the pharmacy level. The approval was based on the…