The Impact of Access to Biosimilars

Hope S. Rugo, MD: We’re very hopeful that access will improve worldwide. In the United States, I think most people have access to biologic therapies. That’s changing with the very expensive immunotherapies that patients stay on, but the immunotherapies are so new and biosimilars are a long way away. Biosimilars play the biggest role, in terms of access, internationally, where people pay out-of-pocket for these agents. And so, many people are not able to afford to use trastuzumab when they have curable HER2-positive breast cancer.

I see this making a huge impact because there are a number of, for example, trastuzumab biosimilars out there. That helps with competition. It’s going to really make people want to make these contracts and drive down the price. Then, hopefully, it will mean that people who previously couldn’t get any HER2-targeted therapies will have access.

The competition, we don’t really know a lot about it yet. I think that the companies that are making these biologic agents, the reference products, are trying new delivery methods and new combinations to try to get around the biosimilar market. So, I don’t know exactly how that competition is going to play out over time. I have seen that the reference biologic companies are going to the regulatory agencies to say, “Hey, we should be able to extend our patent because we got approval in this setting” or “with that combination.”

They first started working on trying to extend their patent and are now looking more at trying to have novel delivery mechanisms or some new combination that’ll make them competitive. For example, I mentioned that pegfilgrastim now has a novel delivery system where you put the patch on and trigger it. The next day, it delivers the growth factor and you peel it off and throw it out, right? That’s a great method of competition. Not having to come back means that you’re going to treat people. They’re going to want to get that drug instead of the one that they have to come back for. So, there are a number of different ways that you can compete with the agents.

Cornelius F. Waller, MD: The financial impact of the development of biosimilars to the health care system is not yet completely clear. In the United States, there have been 2 agents registered over the past years in supportive care.* The first biosimilar antibodies may come this year or next year. Therefore, there’s not much experience. In Europe, there has been much more experience over the past 10 years. If you consider biologics being a major part of the health care system, which was, for example, analyzed in the United States in 2009, approximately 32% of the budget went into biologics for Medicare. In 2014, this was approximately $9.5 billion. Nine years later, it was approximately double the amount in percentages and approximately $26 billion. You can see what an impact cheaper biologics might have on the entire system.

Therefore, I consider the development of biosimilars a big chance for the health care system if the prices of biosimilars will be marketing lower than the reference products. This should be seen by analyzing the health care costs in different countries. If you look, for example, in Germany, we now have a market share for the biosimilar filgrastim of approximately 75% to 80% of the prescriptions being done. The price range shows that the biosimilars are approximately 30% less cost intensive versus the reference products. We should see a major reduction in costs due to biosimilars. This money can be spent on the development of new drugs and to help more people become insured, for example, in the United States.

*as of the date of filming.