Dr. Kolberg on Ensuring Confidence With Biosimilars in Oncology

Hans-Christian Kolberg, MD
Published: Wednesday, Dec 12, 2018



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 the importance of ensuring confidence with biosimilars in oncology.

When it comes to biosimilars, the most important thing is confidence, says Kolberg. Many physicians do not have a choice as to whether to give a biosimilar or a biologic. Instead, pharmacists mandate whether to use a biosimilar or a biologic. Moreover, many countries have to meet biosimilar quotas. In some regions of Germany, biosimilars have to account for 30% of therapy, explains Kolberg.

Therefore, giving physicians the confidence to acknowledge that using a biosimilar is as safe and effective as a biologic is crucial. Kolberg says this can be done by discussing the scientific justification behind extrapolating evidence on biosimilars, and explain how that folds into the concept of totality of evidence. If a biosimilar exhibits the same mechanism of action as that of the reference biologic, there is no reason to believe that it would behave differently, states Kolberg.
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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 the importance of ensuring confidence with biosimilars in oncology.

When it comes to biosimilars, the most important thing is confidence, says Kolberg. Many physicians do not have a choice as to whether to give a biosimilar or a biologic. Instead, pharmacists mandate whether to use a biosimilar or a biologic. Moreover, many countries have to meet biosimilar quotas. In some regions of Germany, biosimilars have to account for 30% of therapy, explains Kolberg.

Therefore, giving physicians the confidence to acknowledge that using a biosimilar is as safe and effective as a biologic is crucial. Kolberg says this can be done by discussing the scientific justification behind extrapolating evidence on biosimilars, and explain how that folds into the concept of totality of evidence. If a biosimilar exhibits the same mechanism of action as that of the reference biologic, there is no reason to believe that it would behave differently, states Kolberg.

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