oncologist biosimilars ASCO FDA RSP

Medical Oncologists’ Knowledge and Perspectives on the Use of Biosimilars in the United States

by John Devin Peipert, PhD, Karen Kaiser, PhD, Sheetal Kircher, MD, George J. Greene, PhD, Sara Shaunfield, PhD, Katherina Hauner, PhD, David Cella, PhD, and Daniel K. Mroczek, PhD

Jan 9^th 2023
9 mins
JCO Oncology Practice Volume 19, Number 3

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Summary

Most oncologists (88%) treated patients with biosimilars, and 63% reported that biosimilars were required at their institutions.
Approximately half (52%) correctly identified that biosimilars are not the same as generic medicines.
Common barriers to biosimilar use included concerns about insufficient research, potential for extrapolation, and efficacy limitations.
More oncologists from university hospitals were concerned about biosimilar efficacy compared to those from community/private hospitals or private practices.
A high proportion of oncologists emphasized the importance of information on safety (99%) and efficacy (99%) in deciding to use biosimilars.
Less than half (40%) reported that their institution provided education about biosimilars.
The study concluded that educational programs on biosimilars for oncologists are necessary and highlighted the need for improved access to information.

To assist in cost containment across medicine, the Biologics Price Competition and Innovation Act of 2009 was enacted to create an abbreviated approval pathway for biological products that are very similar to approved biologics. Where patents for successful biologics are expiring, biosimilars are rising to take their place, promising significant reductions in costs without compromising the safety and efficacy of their associated reference drugs (bio-originators).

Since the first biosimilar was approved in the United States by the US Food and Drug Administration (FDA) in 2015, the FDA has approved 33 biosimilar products, and 17 of these are approved for use in cancer treatment or supportive care. Biosimilars have been developed and marketed as lower-cost alternatives to newer biologic treatments that have the potential to drive competitive pricing with bio-originators. Regarding oncology specifically, patents that expired on multiple biologic products in 2020 account for more than $20 billion US dollars in health care spending, and biosimilars are expected to claim larger market share...

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oncologist, biosimilars, ASCO, FDA, RSP