Biosimilars

Trastuzumab-dttb (Ontruzant) is now officially available for clinical use in the United States.

The FDA has accepted a biologics license application for a proposed biosimilar for bevacizumab.

Ruth O’Regan, MD, shares her perspective on the use of biosimilars in breast cancer and their future in oncology.

Lee Schwartzberg, MD, FACP, advocates for the increased use of biosimilars in oncology and discusses the benefits of these agents for patients and providers.

Adam M. Brufsky, MD, PhD, FACP, discusses the emergence of biosimilars in oncology and how he anticipates they will change the paradigm.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab biosimilar PF-05280586 for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

Three biosimilars—bevacizumab-bvzr (Zirabev), rituximab-pvvr (Ruxience), and trastuzumab-qyyp)—will become available in the United States at a substantial discount to their reference products.

Ruth O’Regan, MD, and Adam M. Brufsky, MD, PhD, FACP, both discuss the emergence of trastuzumab biosimilars in breast cancer.

Francisco J. Esteva, MD, PhD, discusses the cost-saving potential of biosimilars in breast cancer and historical experience with their use.

Howard "Skip" A. Burris, III, MD, chief medical officer and president, Clinical Operations, Sarah Cannon Research Institute, 2019 ASCO president-elect, and a 2014 Giant of Cancer Care® in Drug Development, discusses the incorporation of biosimilars in oncology.

Thomas Helleday, PhD, professor of Translational Oncology, director of the Weston Park Cancer Centre, Department of Oncology and Metabolism, The Medical School, The University of Sheffield, discusses the similarity of biosimilars and biologics.

Julie R. Gralow, MD, discusses the emergence of biosimilars in the United States and globally.

A biologics license application has been submitted to the FDA for the rituximab biosimilar ABP 798.