Schwartzberg Sheds Light on Rise of Biosimilars in Oncology

Lee S. Schwartzberg, MD

Lee S. Schwartzberg, MD

The additions of biosimilars for trastuzumab (Herceptin), bevacizumab (Avastin), and rituximab (Rituxan) to oncology have proven to be of significant value for patients across a number of tumor types, according to Lee Schwartzberg, MD, FACP.

“We now have biosimilars in oncology for bevacizumab, rituximab, and trastuzumab. All 3 are commonly used biological antibody agents,” said Schwartzberg, executive director, West Cancer Center, chief and professor of medicine, Division of Hematology/Oncology, University of Tennessee Health Science Center. “These drugs are available at a discount to the originator product and we have already seen significant uptake for the use of biosimilars—they have tremendous value.”

In an interview with OncLive, Schwartzberg advocated for the increased use of biosimilars in oncology and discussed the benefits of these agents for patients and providers.

OncLive: How will the additions of biosimilars impact treatment decisions for patients?

Schwartzberg: My personal opinion is that biosimilars can be used in place of originators in any of the FDA-approved indications. [The biosimilars of] bevacizumab and trastuzumab are already in use in my clinic. We have started every new patient, who has an appropriate indication in the variety of diseases, on either bevacizumab or trastuzumab. In many cases, we are switching patients who are already on the originator product, with informed consent and telling them that we have a new product that works the same way and is available and saves money for them. It has been a smooth transition to using biosimilars in oncologic indications.

Why has there been hesitation to using biosimilars in the United States? What can be done to combat that?

Any resistance to using biosimilars in the United States is a function of their newness and a lack of understanding of the rigorous process by which the FDA approves these drugs. This is a different process [compared with] the way originators are approved. Physicians are [most] comfortable with a lot of clinical trials being done.

What you are trying to prove for a biosimilar is that the molecule works the same as the originator and has nothing more than minor differences in inactive parts of the molecule. Then, what you are saying is that [the biosimilar] is another version of the same drug and you do not have to repeat clinical trials.

There is typically a discount because the cost of development is substantially less, but there are good safeguards around the fact that [biosimilars are] going to work the same and have the same safety. Because it is a different process and is fairly new, and [physicians and patients] did not grow up with biosimilars, it takes some time for them to understand that this is a different way of getting to the same endpoint.

Ultimately, how will biosimilars impact healthcare?

In general, payers will react favorably to biosimilars because they look at the weight of the evidence and are comfortable with their advisors that this is a good substitution. It saves money for them and for patients that are buying their health plan—it saves money across the board.

The hook comes up in contracting. Sometimes there is a value to the payer to take the originator based on other contractual relationships, and that is complicated. Therefore, many payers do what is called step therapy, which I, as a provider, am very much against because [that means the payers] are essentially prescribing a drug and telling [the physicians] which drugs to use.

This is not exactly the same thing because it is a biosimilar, but from a process perspective [it is similar]. [This can occur] if I am starting a patient on a biosimilar and then I have to switch to the originator. [This probably happens] because the payer had not gone through the paperwork of reimbursement and entering it into their system, causing us to use the originator product. The payer was not yet prepared to use the biosimilar, even though they acknowledged that, in the end, it will save money.

The system is so complex that there are many things that have to happen in the chain of reimbursement and how things get entered [into the system]. It can be variable and, at the practice level, that is complicated because it means we have to stock multiple drugs, keep inventory, and make sure that the right drugs are delivered. It adds complexity, which to be honest, is not warranted.

What is your advice for physicians as biosimilars start to be implemented in practice?

I would advise my medical oncology colleagues to become comfortable with biosimilars, understand their value, study the evidence that is available and the process by which biosimilars are approved. The comfort level will grow while making sure [my colleagues] pay attention to the operational components of biosimilars, as well.

How do you recommend having conversations with patients about biosimilars, especially if patients are transitioning from the originator to the biosimilar?

The conversation with a patient goes something like, "We have a new version of the medication you are taking that was approved by the FDA and went through a rigorous process. It costs less because it did not have to be developed from ground zero and [in studies] we just have to make sure that the molecule works exactly the same as the originator."

The concept of it is not a different drug, but it is a highly similar drug. We can also say that these drugs are complicated, and each batch is a little different, but we are very comfortable that they all work the same.

What do you anticipate the future of biosimilars to look like?

The future of biosimilars is rosy and substantial. It is really dependent on once you have a drug that has gone through the process, has been on the market, and the patent expires. Then, there are companies that want to make a biosimilar at a lesser cost. We have seen that with every biologic so far, where the patent has expired—in oncology, rheumatology, or other disciplines.

Now, many of the major pharmaceutical manufacturers who make originators are also making biosimilars with the same kind of quality assurance. They treat their originator products with a reliable company; making this kind of drug at a cost differential is a good thing.