Michael A. Savin, MD, assistant professor of medicine, School of Medicine, Oregon Health and Science University, discusses the challenges that come with trying to develop a clinical trial for biosimilars.

Mainly, clinical trials in general are very expensive to run. There are a number of cooperative groups that can provide assistance, but they have limited resources. This means that researches become reliant on drug manufacturers to help fund the trials, which leads to some setbacks. Savin says that these companies might not be willing to support a trial that could devalue one of their products—particularly biosimilars, which aim to hit the same target at a lower cost.

An important step for oncologists to take would be to find more effective ways of funding trials, Savin says.

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Dr. Savin on the Challenges of Developing Biosimilar Clinical Trials

Michael A. Savin, MD, assistant professor of medicine, School of Medicine, Oregon Health and Science University, discusses the evolution of biosimilars.

The Europeans are ahead of the United States in terms of biosimilars, Savin explains. This may be because they are more cost driven than American counterparts, he adds.

The United States is being driven toward biosimilars as drug prices continue to increase. Twenty to 30 years ago, tamoxifen was a very expensive drug. Previously, an expensive drug was defined as $200 or $300 per month, he says. Now, physicians prescribe drugs that are much more. Biosimilars may be a means of reigning these costs in, he concludes.

Dr. Savin on the Evolution of Biosimilars

Michael A. Savin, MD, assistant professor of medicine, School of Medicine, Oregon Health and Science University, discusses the future of biosimilars in oncology.

The future of biosimilars is a tough question, says Savin. That may be where a lot of the resistance comes from. It comes down to how you see the data, because biosimilars are not bioidenticals. Savin notes that physicians do not worry about whether it will hit the right target, but that the dynamics of its interaction with that target may be different. The degree to which it binds to the target and how easily it comes off of the target may likewise be different. Another consideration is whether it is going to make a difference if the molecular target on the cell has a certain shape. The efficacy may be hindered by that as well.

Part of the reason why physicians use pertuzumab (Perjeta) in addition to trastuzumab (Herceptin) is because they both target the HER2 molecule at different places. They also take away part of the molecule’s ability to hide. This is one reason why those two together have added another dimension to treatment, says Savin.

Michael A. Savin, MD

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