Dr. Schmid on Challenges Concerning Biosimilars in Oncology

Peter Schmid, MD, PhD, lead at the Centre for Experimental Cancer Medicine, Barts Cancer Institute, discusses challenges with biosimilars in oncology.

One of the main challenges that exist in bringing biosimilars to market is their demonstration of bioequivalence to the reference product, says Schmid. Furthermore, some of the confidence intervals for demonstrated equivalence are wide, making it difficult to discern a potential detriment or difference with a biosimilar.

There is a possibility that biosimilars may be more effective than their biologic counterparts, he adds. Even if the same antibody is used to the construct the product, its interaction with a patient’s immune system may manifest differently as a result of glycosylation. Increasing data point to the fact that the activity of antibody-based therapy is triggered through the immune system, leading to further skepticism surrounding the idea of similarity, especially in the curative setting. However, regulatory agencies are in place to ensure that trials are conducted appropriately to assess similarity and produce robust data.