Dr. Kolberg Discusses Considerations With FDA-Approved Biosimilars

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 considerations for FDA-approved biosimilars.

The phase III LILAC study, which evaluated the trastuzumab (Herceptin) biosimilar ABP 980, showed a pathologic complete response rate equivalent to that of the reference biologic. This was the first study of a biosimilar in neoadjuvant breast cancer to include a central pathology review, as well as instances of switching patients from trastuzumab to ABP 980.

Now that biosimilars are beginning to be approved by the FDA for the treatment of patients with cancer, questions have arisen about how these agents perform in combination. It is not known whether the biosimilar will behave the same as its reference product in combination, and for a biosimilar of trastuzumab, a biologic that is used exclusively in combination, that is important to know. Kolberg says that clinicians should be confident that biosimilars will perform as well as the reference product in combination.