The Role of Biosimilars.

Abstract

As biologics go off-patent, the field of oncology is grappling with incorporating biosimilars. These are highly similar (but not generic versions of) biologic agents, and they are approved based on showing "near fingerprint identity" in structure and potency. Their introduction is expected to increase competition and lower treatment costs. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Myeloid Growth Factors has incorporated the first biosimilar approved in the United States, filgrastim-sndz, into its recommendations. At the NCCN 21st Annual Conference, Andrew D. Zelenetz, MD, PhD, provided an overview of biosimilars, describing the process of their development and approval; Pamela S. Becker, MD, PhD, discussed the NCCN Guidelines recommendations for the use of filgrastim-sndz and of tbo-filgrastim, which was approved in the United States as a true biologic agent. The use of tbo-filgrastim can be somewhat confusing, as it does not have the same indications as the other growth factors.