Dr. Kolberg on the Safety Profile of Trastuzumab Biosimilars in 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 cost reduction and safety of biosimilars, specifically ones for trastuzumab (Herceptin) biosimilars in breast cancer.

Biosimilars, unlike their biologic counterparts, can be developed for around $200 million as opposed to over $1 billion for a new antibody, according to Kolberg. Therefore, biosimilars can lead to significant savings in healthcare, especially in developing countries where biosimilars may offer an opportunity to gain access to antibodies, explains Kolberg.

While biosimilars can help make healthcare more affordable, physicians must feel confident that the biosimilars are safe in order to prescribe them. For trastuzumab biosimilars in breast cancer, this involves looking closely at cardiac safety, which has been an issue with the reference product. Biosimilars are always looked at with a “totality of evidence,” meaning authorities examine the clinical signals, safety signals, pharmacokinetics, and pharmacodynamics much closer than they do with the originators, concludes Kolberg.