Adam M. Brufsky, MD, PhD
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.
Brufsky, professor of medicine, associate chief, Division of Hematology/Oncology, co-director, Comprehensive Breast Cancer Center, associate director, Clinical Investigation, University of Pittsburgh, commented on the FDA approval of MYL-1401O and discussed the adoption of biosimilars in oncology.
OncLive: Can you provide some background on the HERiTAge study?
The idea behind a biosimilar is that is it similar; it is not superior and it is not inferior. It is very important to understand that. That means, before a biosimilar even gets to a clinical trial, there has to be protein assays, protein electrophoreses, and glycosylation assays that show similarity to the originator compound. All of that has to be done before it gets to human beings. Once you get to human beings, within a confidence interval, it has to show that it is similar—it cannot be inferior or superior. In fact, one biosimilar did not get an approval because it was superior. It is very important to be within the confidence interval.
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