Roy Fleischmann, MD: The Current State of Biosimilars

In the second part of our biosimilars series, Roy Fleischmann, MD, examines the current state of biosimilars as it relates to rheumatologists in the United States. 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: How can rheumatologist help patients accept biosimilars?

Roy Fleischmann, MD: The way the rheumatologist introduces the topic of the biosimilar and explains the topic is what's really important. If I said, “I'm going to give you a drug, because it's cheaper, may not be quite as good, but it's cheaper,” there are [some] patients who will say, “Well, it's not quite as good, but it may work so I'll try it.” But I think most would say, “If I can afford the biooriginal, I'd rather do that.” If I [explain] that these drugs are truly similar, it's cheaper to you, and you have a 90% to 95% chance of not being able to tell the difference, I think patients will accept it. So it really is how the physician or how the health care provider, whoever that is, really explains what the biosimilar does, how similar it is to the biooriginal, and why you'd want to do it. But it's still going to come down to cost. I have friends in the United Kingdom who have had biosimilars for years. The drugs have come down from $60,000 or $70,000 a year to $2000 a year. Theoretically, more patients can get on the drug, except the British healthcare system is almost as broken as ours because you still have to have high disease activity before you can get a biologic. But in those patients, it should be much more available and more patients should be able to get on these drugs who are not on these drugs at present. I think the rheumatologist needs to understand that there's no reason not to encourage the patient to switch.

Now the only problem, which I think is going to be resolved probably relatively soon, would be the concern whether a patient switching to a biosimilar would respond as well as the biooriginal. The biosimilar companies did something which I thought was inappropriate. There are patients who do not respond to the biosimilar as well as they do to the biooriginal. The companies said this is a nocebo effect. The nocebo effect is the opposite of a placebo effect in which the patient thinks that the drug doesn't work as well but they wrong. However, it probably isn't in a nocebo effect. There probably are patients who do not respond as well. So that was the original question. Can you switch the patient back? Well, in many countries, that's exactly what they did. If the patient doesn't feel that they're responding, they do go back to the original. So, let's handle that problem.

The second problem is if the patient's better on the biooriginal and then you switch to a biosimilar, will the patient have a reaction? And I've done published trials, and there are many trials, that show that a switch from biooriginal to biosimilar really does work quite well. If you start with a biooriginal, go to a biosimilar, and then go back to the biooriginal, will that be problematic? There are studies on that which have shown it's not. Or the reverse, we started biosimilars, then biooriginal, and then back to the biosimilar. Is that problematic in terms of losing effect? And I've done those studies and it's not. But what about going from a biooriginal to a biosimilar, then to another biosimilar, then to a different biosimilar, and then back to the biooriginal, and then back to the second biosimilar? Because the prices change week by week, right? And that is [currently] occurring in the UK with a patient going from one to the other to the other. And it can be every week, every 2 weeks, or every 3 weeks. Will you develop neutralizing antibodies to the biosimilars? Will it lose effectiveness? That's still a concern. But I think that that's being answered in the real world as this occurs and I have not seen reports yet that there are patients who really do run into the problem of developing neutralizing antibodies to that molecule. That’s the one small area of concern that I have.

In summary, I think the Biosimilars are quite reasonable, cheaper, and they should be used only if they are cheaper to the patient, not to the insurance company. I haven't seen insurance companies drop my premium any year. As a matter of fact, I see significant increases in my premium. Even if these prices come down, it has to be cheaper to the patient. And I think if that occurs, there will be more and more use of the biosimilars.