Hans-Christian Kolberg, MD, head of the department of obstetrics and gynecology, breast cancer center, and gynecologic cancer center at Marienhospital Bottrop, Germany, discusses the role of real-world evidence for biosimilar trastuzumab.
Real-world data are something that are needed, and actually that is one of the huge problems we have. For companies selling biosimilars, real-world data are after-sales service. It’s very difficult to get funding for that.
We are at the moment planning a study, a real-world study on cardiac safety. We’re trying to predict cardiac safety with early endpoints by drawing blood after 2 cycles of the biosimilar—of antibody—trying to measure in the blood biomarkers that may predict cardiac failure in patients.
This is a classical real-world study, and this is very important because cardiac safety, the cardiac signals in trastuzumab trials, have been decreasing over the years, not because trastuzumab is less cardiotoxic, but because people are more aware of cardiotoxicity, and of course the inclusion/exclusion criteria have been developed and are more strict. So we may ask ourselves, is this really real-world that we’re seeing?
This is why we believe doing a real-world study—and actually, we found a sponsor for that study—it’s very important to include all patients who are, in the real world, candidates for trastuzumab in a safety study, and not only from a clinical registration trial. Of course, inclusion/exclusion criteria are designed so you’re safe for ethical reasons.