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Roy Fleischmann, MD: The Future of Biosimilars

Roy Fleischmann, MD, discusses the usage of biosimilars in the United States and hypothesizes about what is in store for the future.

In the final part of our biosimilars series, Roy Fleischmann, MD, discusses the usage of biosimilars in the United States and hypothesizes about what is in store for the future. Fleischmann is Clinical Professor of Medicine at the University of Texas Southwestern Medical Center at Dallas and co-Medical Director of the Metroplex Clinical Research Center in Dallas.

Rheumatology Network: Why do you believe the usage of biosimilars is not as popular within the United States when compared with other countries?

Roy Fleischmann, MD: If I have a patient, let's say treated with rheumatoid arthritis or psoriatic arthritis, and I started with methotrexate, and the patient doesn't have an adequate response, I want to use an innovative therapy. It could be a biosimilar or could be the biooriginal and, in my mind, both work the same. But many times, the experience has been that the pharmacy benefit manage has insisted on the biooriginal rather than the biosimilar primarily because of the rebate.

RN: How important are patient reported outcomes regarding the implementation of biosimilars?

RF: In terms of patient acceptance, it depends upon how the rheumatologist presents that to the patient. If I were told that a patient is on, for example, etanercept biooriginal, and I must change them to the biosimilar, and I tell the patient that the insurance company demands that I change them to the biosimilar, the patient may have the feeling that the biosimilar is not as potent, effective, or safe as the biooriginal. In most patients, maybe 95% of patients, it is. But because it's a forced switch of a drug that the patient has to do well on, there is a reluctance for many patients to switch.

Why change something that's not broken? If, however, the patient could take the biosimilar or the biooriginal and the access to the patient was better for the biosimilar, it was cheaper to the patient, then the conversation is I have 2 drugs. The biosimilars have been shown that it's generally almost always equal to the biooriginal, the safety seems to be the same, and the cost is cheaper. Why don't we switch for [their] benefit? Then the patient's reaction is different. The patient may still say, “I'm not going to change something's that broken,” But many times the patients say, “Well, if it's the same, why not?” So, it's whether you're forced or not forced and how it was explained to the patient.

RN: What do you believe is in store for biosimilars in the United States?

RF: It depends upon what happens with our healthcare system. Right now, our healthcare system, while I still think is the best in the world, is broken. Were the rebate system to disappear, I think you’d see much more uptake of the biosimilar. If the insurance companies passed on savings, lower copays, that were more affordable to the patient, I think that they would be greatly used and there [would be] no reason why they shouldn't be used in that situation.

RN: What do rheumatologist need to know about the future of biosimilars in 2022 and beyond?

RF: I’m not sure it’s 2022, but I think in 2024 biosimilars will be widely available. Many are approved, but, because of legal issues, they are not utilized (although some are). And I think that many more will be. Again, it depends upon patient access. If the patient access is better, there will be a much bigger uptake. If I can sell you a Ford or I can sell you a Bentley, and they both get you where you want to go, which is much more expensive than the other? Which would you buy? I would pick the Ford. If you told me that they were exactly the same, I'd [ask] which one's more comfortable? Which one has the better gas mileage? Am I still picking the Ford in that situation? It really does come down to economics. If there is no reason for a biosimilar unless it's cheaper, it should be substantially cheaper than the biooriginal.