Biosimilars in the Pipeline and Disease Management

Hope S. Rugo, MD: The whole idea of drug development is a little dry. The biggest challenge we have is in making this very exciting or interesting. It’s something that’s really at hand. Starting with education a couple of years before the first therapeutic entered the market, which we hope will be next year, has been 1 way to do that. It’s kind of interesting. Through nobody’s plan, we started with agents that were used for supportive care. Everybody is a lot more comfortable in that scenario versus when you’re treating somebody with curative intent in the early-stage cancer setting.

Starting with filgrastim and pegfilgrastim will give people experience and make them feel more comfortable with using these agents. And then, as these agents get out into practice, it’s really important to make sure that people understand how we’re using them, what extrapolation means, and what the clinical evidence means. Comparing the different biosimilars is going to be extremely difficult because they all have very good data that support their use as biosimilars. So that’s helpful. I think understanding the lack of immunogenicity is particularly helpful.

Another challenge that providers face is understanding what pharmacovigilance means. One other thing that’s required by the regulatory agencies is that there is very careful pharmacovigilance. You have to look at safety and efficacy in different indications. You have to report, based on this little 4-letter abbreviation after the “tra,” any safety issues that come up. So who’s responsible for pharmacovigilance? How is it reported? Is it done easily? This is something we still need to understand.

Cornelius F. Waller, MD: In the United States, we currently have 11 approved biosimilars and more than 20 in the pipeline, which will come during the next months or years. This is good news for patients. For physicians, this is a challenge. If you have several biosimilars for the same reference product, you need to know the data. You need to know whether there are any differences. In the end, what is good news for everybody is that because several manufacturers are producing biosimilars for the same reference product, there’s price competition. As it is with other goods you produce, if you have more than 1 company offering this compound, the likelihood that the price will be lower is rather high. I think this is good news.

As I said, the fact that you have several biosimilars for the same reference product might cause more discussion regarding which one to use. At our hospital, we discuss which biosimilars to choose. From time to time, we discuss whether we should change anything. The likelihood to have the reference product and 2 or 3 biosimilars in stock for the same reference product, for example, is not being considered by many institutions. It needs to be rediscussed with pharmacists and this commission—the use of drugs within the hospitals. Of course, the price issue is something that the pharmacists and the regional and national agencies will be a part of.

Hope S. Rugo, MD: I don’t think it really changes our management, but it changes the management worldwide. In many countries, for example, you’re only allowed access to 9 weeks of trastuzumab. Or you have to pay for every bit of trastuzumab you receive out of your own pocket. And so having a less expensive drug will completely change access around the world. Because we know these are agents that can cure patients, they can have a really big impact on disease management.

It’s also our hope that having a lower-cost option for drugs that can be given for a long time will free up money for drug development and other drugs that are also lifesaving—for example, the new area of immunotherapy, which adds a huge additional layer of cost and complexity in patient care, particularly for our patients with the most aggressive diseases that stand to benefit most.

We continue trastuzumab forever, right? People in other countries always say, “What?” They stopped because it’s so expensive that they can’t continue it. But if I have a patient who has metastatic HER2-positive breast cancer and she goes on trastuzumab—maybe now with pertuzumab—and she gets chemotherapy, has a great response, and they stop the chemotherapy, if she’s sitting on those 2 antibodies, she can stay on those 2 antibodies forever. At some point, usually at 10 years, I’ll say “OK, you’ve been on therapy for 10 years. Let’s stop the therapy.” Of course, the patient is very anxious about that. Still, they’ve stayed on it for 10 years.

Many other countries, probably most, don’t do that because they can’t afford the drugs. With the significant cost savings—not 15%; it would have to be a lot more than that—people will be able to stay on the drug longer and will potentially have better survival as well. So I think that there is a potential impact on patient outcomes by having the drugs become more accessible, just not so much in the United States.

Cornelius F. Waller, MD: In the future, the availability of biosimilars and biologics will change the way of treatment in countries that are not in the situation to be able to afford these drugs so far. I think there will be a major change for treatment. The use of filgrastim or monoclonal antibodies, for example, will lead to better outcomes in patients with cancer. Therefore, it is to the benefit of patients being treated there. In the Western countries, the availability of the reference product as well as the biosimilars did not change the use of these compounds very much overall. Here the situation, with regard to quality of treatment, is not really affected.