Dr. Brufsky Discusses Biosimilar Development and Approval

Adam M. Brufsky, MD, PhD, professor of medicine, associate chief, Division of Hematology/Oncology, co-director, Comprehensive Breast Cancer Center, associate director, Clinical Investigation, University of Pittsburgh, discusses the development and approval of biosimilars in oncology.

In December 2017, the FDA approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst) for patients with HER2-positive breast cancer, as well as metastatic gastric or gastroesophageal junction adenocarcinoma, based on the findings from the HERiTAge study. MYL-1401O demonstrated an overall response rate (ORR) of 69.6% after 24 weeks among women who received MYL-1401O in combination with a taxane compared with a 64% ORR for patients who took trastuzumab plus a taxane.

Before a biosimilar reaches a clinical trial, there must be protein assays, protein electrophoreses, and glycosylation assays that show similarity to the originator compound. Once the biosimilar reaches humans, it must show that it is similar within a confidence interval—it cannot be inferior or superior, Brufsky says. MYL-1401O was within the confidence interval, leading to its approval.