Dr. Tripathy on the Importance of Biosimilars in Oncology

Debu Tripathy, MD, professor and chairman, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the importance of biosimilars in oncology.

In general, biosimilars are an important part of having a more robust infrastructure to care for patients, says Tripathy. Diversity in available therapeutic options is as important in oncology as having diversity in consumer products, says Tripathy. The development of biosimilars also enables healthy competition and allows for better pricing structures to evolve over time.

The only question, says Tripathy, is whether these agents are truly similar to the originator drug. It is difficult to discern whether biosimilars have the same effect as originator drugs because biologic agents have many variations, explains Tripathy. The threshold to get a biosimilar approved is not the same as getting the first version of the drug approved.

Biosimilars have to show that one of the coprimary endpoints of the originator drug is the same. As is the case with many biosimilars in breast cancer, it is often the response rate that demonstrates equivalence. Biosimilars also have to demonstrate similar pharmacokinetics and toxicity profiles.