Dr. Verma Discusses Biosimilars in the Oncology Sphere

Sunil Verma, MD, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre, discusses biosimilars in the oncology sphere.

There are at least 7 new biosimilars that are currently being investigated, says Verma. In Europe, there was a recent approval of a biosimilar from Samsung Bioepis based on a neoadjuvant study. The FDA recently approved a trastuzumab (Herceptin) biosimilar from Mylan, MYL-1401O (Ogivri; trastuzumab-dkst), based on the HERiTAge study.

The approval of the trastuzumab biosimilar was based on data for early-stage breast cancer, but was also extrapolated to the gastric cancer setting. Issues with the implication of biosimilars into practice include interchangeability, automatic substitution, and extrapolation, says Verma. Clinicians need to familiarize themselves with these factors, as well as the implications of the biosimilar framework for regulatory agencies, when incorporating biosimilars into practice, he explains.