Dr. Verma Discusses the Approval Process for Biosimilars

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 the FDA approval process for biosimilars.

As biosimilars begin to enter the cancer space, Verma encourages clinicians to review the regulatory framework that exists for the approval of biosimilars. Clinicians must understand that it is not the same clinical assessment framework that is used when assessing innovative products. Unlike novel agents, clinical trial information is not the key driving factor in the approval process for biosimilars.

A study must show a biosimiliars similiarity to the originator drug in its pharmacokinetics, immunogenicity, and efficacy outcomes. The biosimilar must be similar within a confidence interval—it cannot be inferior or superior. Although, the framework is driven more by the regulatory agencies, which identify the manufacturing and clinical quality attribute assessment, Verma explains.