Dr. Brufsky Discusses Reasons to Use Biosimilars in Oncology

Adam M. Brufsky, MD, PhD
Published: Tuesday, Nov 06, 2018



Adam M. Brufsky, MD, PhD, professor of medicine, associate chief, Division of Hematology/Oncology, co-director, Comprehensive Breast Cancer Center, associate director, Clinical Investigation, University of Pittsburgh, discusses reasons to use biosimilars in oncology.

Brufsky says that biosimilars should not pose a problem in oncology as long as physicians are properly educated about what they are. Biosimilars are similar to reference biologics in their molecular shape, efficacy, and safety profile, are neither superior nor inferior. They have to go through a rigorous development and approval process to demonstrate that similarity, explains Brufsky.

In theory, biosimilars should be interchangeable. The issue, he explains, is the reason for their use. Because of a biosimilar’s noninferiority, the only reason for their use would be for price and competition. Based on approval criteria, there is no reason to believe that giving biosimilar trastuzumab (Herceptin) over reference trastuzumab would be of more clinical benefit to a patient.
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Adam M. Brufsky, MD, PhD, professor of medicine, associate chief, Division of Hematology/Oncology, co-director, Comprehensive Breast Cancer Center, associate director, Clinical Investigation, University of Pittsburgh, discusses reasons to use biosimilars in oncology.

Brufsky says that biosimilars should not pose a problem in oncology as long as physicians are properly educated about what they are. Biosimilars are similar to reference biologics in their molecular shape, efficacy, and safety profile, are neither superior nor inferior. They have to go through a rigorous development and approval process to demonstrate that similarity, explains Brufsky.

In theory, biosimilars should be interchangeable. The issue, he explains, is the reason for their use. Because of a biosimilar’s noninferiority, the only reason for their use would be for price and competition. Based on approval criteria, there is no reason to believe that giving biosimilar trastuzumab (Herceptin) over reference trastuzumab would be of more clinical benefit to a patient.



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