Dr. Cuellar on Concerns With Extrapolating Data for Biosimilars

Sandra Cuellar, PharmD, BCOP, oncology resident director, clinical pharmacist, and team leader, Ambulatory Pharmacy Services, clinical assistant professor, Pharmacy Practice, College of Pharmacy, University of Illinois, discusses challenges with ​data extrapolation for biosimilars. 

A knowledge gap​ remains among the health care community regarding the approval process for biosimilars and the differences compared with that of biologics, says Cuellar. Moreover, the oncology field is still trying to adapt to this paradigm shift. 

Biologics are generally studied in individual tumor types, whereas data for biosimilars can be extrapolated to other tumor types. This has caused some hesitancy in the field of oncology, Cuellar says.

​Moreover, due to the complexity of the molecules, many have questioned the overall utility of biosimilars, Cuellar concludes.