Dr. Esteva on Clinical Trial Design of Trastuzumab Biosimilar in HER2+ Breast Cancer

Francisco J. Esteva, MD, PhD, medical oncologist, New York Langone Medical Center, discusses the importance of having a clinical trial of the trastuzumab (Herceptin) biosimilar MYL-1401O for patients with HER2-positive breast cancer.

One of the key differences between the investigation of biosimilars and generic agents is that biosimilars need to demonstrate that they have the same molecular structure and function as its branded competitor, Esteva explains. Additionally, in clinical trials, it is important to show that the biosimilars are safe and effective in comparison with the other drug. In regards to MYL-1401O, the FDA will examine the totality of the data in how this agent performs in patients with HER2-positive breast cancer.

MYL-141O would be the second biosimilar approved in the United States, following the approval of the neupogen biosimilar Zarxio that is used for palliative care, Esteva adds.