Dr. Kolberg Explains the Approval Process for Biosimilars

Hans-Christian Kolberg, MD
Published: Thursday, Jun 28, 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, explains the approval process for biosimilars.  

The approval process for a biosimilar is different than it is for a new original drug. Kolberg says that pharmacokinetic and pharmacodynamics studies need to be done first. This will be the first instance of clinical data on the biosimilar. The biosimilar then moves on to a phase III study with an efficacy endpoint. In the phase III trial, Kolberg says that the biosimilar can only be evaluated in 1 of the indicated tumor types for which the originator drug is approved. The efficacy data can then be extrapolated.  

The trastuzumab (Herceptin) biosimilar ABP 980 is approaching approval in the European Union, as the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of the biosimilar. This biosimilar would be indicated as a treatment for patients with HER2-positive metastatic breast cancer, HER2-positive early breast cancer, and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction. It is currently being studied in HER2-positive 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, explains the approval process for biosimilars.  

The approval process for a biosimilar is different than it is for a new original drug. Kolberg says that pharmacokinetic and pharmacodynamics studies need to be done first. This will be the first instance of clinical data on the biosimilar. The biosimilar then moves on to a phase III study with an efficacy endpoint. In the phase III trial, Kolberg says that the biosimilar can only be evaluated in 1 of the indicated tumor types for which the originator drug is approved. The efficacy data can then be extrapolated.  

The trastuzumab (Herceptin) biosimilar ABP 980 is approaching approval in the European Union, as the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of the biosimilar. This biosimilar would be indicated as a treatment for patients with HER2-positive metastatic breast cancer, HER2-positive early breast cancer, and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction. It is currently being studied in HER2-positive breast cancer.

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