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Sunil Verma, MD, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre, discusses challenges with integrating biosimilars into practice.
Sunil Verma, MD, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre, discusses challenges with integrating biosimilars into practice.
Verma says that there are certain nuances with biosimilars that will prove challenging in the oncology space. With the approval of biosimilars such as MYL-1401O (Ogivri; trastuzumab-dkst) and ABP-215 (bevacizumab-awwb; Mvasi), many in the community are questioning whether the decision to integrate biosimilars is driven by regulatory agencies and insurance providers, as opposed to clinicians.
It is critical to have strong pharmacovigilance programs and strong naming programs, Verma says. These will allow clinicians to measure benefit prospectively in routine and clinical practice. In most of the trials that have been done, the interim endpoints have been pathologic complete response, response rate, or progression-free survival. Long-term data is not yet available. As biosimilars move close to clinical practice, these are challenges that need to be addressed, Verma adds.