Cornelius F. Waller, MD: If the current biosimilars should fail to actually lead to cost reduction in the healthcare system, it will be interesting to see what will happen. For a manufacturer, it is necessary to get the money out of the development of such a drug afterward. If this is not the case, you may need to reconsider. I am skeptical that this is going to happen. I am very optimistic, actually, that the use of biosimilars will lead to cost reductions and that the money being saved can be used on new, innovative products.
Hope S. Rugo, MD: What happens with cost? That’s one of the issues that has come up a lot. With a 15% savings, is it worth it? Does it make a big difference to us? Does it need to be 30%? Does it need to be 70%? In some countries, to really make an impact on how accessible drugs are to the population, it probably needs to be a 70% reduction.
I think that the competition between the different biosimilars that are out there will allow for substantial pricing differentials. If they say, “If you say you’re going to only use our drug, we’re going to give it to you at a 40% discount,” that kind of competition can really allow for much greater cost savings. So I think that we will see cost savings. I don’t really see that the market will collapse because we didn’t see any cost savings.
If my predictions are wrong and nobody uses biosimilars, that whole area will collapse. In the general approach of pharmaceuticals and cancer care, the competition has been a really important part of drug development. It has really benefited our patients. I hope that’s still the case.
Cornelius F. Waller, MD: I believe that in rheumatology or gastroenterology, as well as in oncology, the progress being made in the development of biosimilars will lead to quality care for these patients. One could imagine that, for example, inCrohn disease or ulcerative colitis, the use of these monoclonal antibodies, because of the reduced costs, may lead to an earlier use of these drugs throughout the course of the disease.
However, this is speculative. I think clinical trials need to be performed before one can consider this true. I think this is an option in countries where there’s not such a high budget in healthcare. In all 3 areas, the availability will lead to better treatment results because of more use of these drugs.
Hope S. Rugo, MD: You can basically group these into rheumatologic diseases and cancer. As agents go off patent, we’re largely going to be replacing those agents with biosimilars. Or the reference biologic products are going to just match the pricing of the biosimilars.
We’re going to see that shift over time, but we keep entering new biologics into the area, right? We just got immunotherapy. We have new antibodies that are HER2-targeted. We have a lot of other agents that target different biologic pathways. We’re always going to have agents starting the patent process while other agents come to the end of their patent life. This is going to be an ongoing change where we will see different options available around the world, in terms of the costs of agents and better access.
I think that the whole area of biosimilars is a nice example of the interplay between regulatory bodies, pharmaceutical companies, and patient access in drug competition. Overall, I think there are some feelings against some regulations and regulatory bodies and how they sort of control different ways of using agents.
In the United States, we’ve largely believed that’s a way to protect patient safety. Now we’re seeing that the regulatory agencies are also helping to create a competitive environment that will improve access, reduce cost, and free up some of the money for the additional development of new agents and access to novel agents.
To me, it has really been a fascinating time to see that go into play—to see our first approvals of therapeutic biosimilars in the United States and Europe. To some degree, I think we’ve seen it in India, but I hope we’ll see it around the world—in the long term, this can provide access for patients who can’t afford lifesaving drugs or don’t have access because of the competition of biosimilars. I think that is a really big step. This is important progress. Even though our patients in the United States have access to biologic agents, this can only move our ability to care for our patients better forward, in a positive way.