Hans-Christian Kolberg, MD, discusses collecting real-world data for biosimilars, specifically the trastuzumab biosimilar ABP 980 for breast cancer.
Hans-Christian Kolberg, MD, head, Department of Obstetrics and Gynecology, Breast Cancer Center, and Gynecologic Cancer Center at Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe, Bottrop, Germany, discusses collecting real-world data for biosimilars, specifically the trastuzumab (Herceptin) biosimilar ABP 980 for breast cancer.
Real-world data are needed for biosimilars, Kolberg explains, but it is difficult to get funding for it. Kolberg and his team are planning a real-world study on the cardiac safety of ABP 980 by drawing blood after 2 cycles of the biosimilar or antibody. Patients who are real-world candidates for trastuzumab must be included on the safety study, and not only for a clinical registration trial.
The researchers are also going to try to measure biomarkers that may predict cardiac failure in patients. This is important because the cardiac signals in trastuzumab trials have been decreasing over the years, not because trastuzumab is less cardiotoxic, but because researchers are more aware of the associated cardiac toxicities and the inclusion and exclusion criteria are stricter, concludes Kolberg.