Roy Fleischmann, MD: History and Implementation of Biosimilars in Rheumatology

As a part of our biosimilars series, Rheumatology Network interviewed Roy Fleischmann, MD, to discuss the history of biosimilars as well as his thoughts on implementing biosimilars 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: Can you give me a bit of background on biosimilars?

Roy Fleischmann, MD: In 1988, the first tumor necrosis factor (TNF) was approved, which is etanercept, followed by infliximab, and then adalimumab. And then 2 other TNFs, golimumab and certolizumab, as well as other biologic agents, an interleukin 6 (IL-6) inhibitor, a costimulatory molecule inhibitor, and a B-cell inhibitor [were implemented]. These medications are quite effective in rheumatoid arthritis and helped many patients in many ways. However, they're not perfect because not all patients go into remission. One of the problems with the development of these drugs is that they are very expensive to produce and therefore the cost was quite high. Prior to the patents expiring, there were other companies that developed biosimilars. Biosimilars are identical to the biooriginals in terms of their amino acid sequence, but there can be certain differences in folding and manufacturing and so on and so forth. It was hoped that the biosimilars would be equally effective to the biooriginal, which they appear to be in clinical trials with very similar efficacy and safety and they are cheaper. Because they're cheaper, there should be much more access to these drugs. One of the problems with them, because of the cost, is access. Can the patient really afford them? That was the reason for beginning to develop biosimilars.

RN: What are your thoughts on implementing biosimilars?

RF: Let me start out by saying that I think that biosimilars are, in most patients, very similar to the biooriginal. Most patients who will respond to the biooriginal will respond to the biosimilar. The question, though, is in terms of access. In the United States, it's been very difficult to get access to the biosimilars in terms of the willingness of pharmacy benefit managers to utilize biosimilars. The problem in the United States is the rebate system. A developer of the biooriginal can pay a rebate to the pharmacy benefit manager. And that is quite profitable to a pharmacy benefit manager. What we're seeing now is that most pharmacy benefit managers will ask for use of the biooriginal because of that rebate. And there are entities that do use the biooriginal. But what's problematic is that although they're cheaper, in many cases it’s not cheaper to the patient. The patient still has the same copay, and they have the same problems they have with the biooriginal. They may be cheaper to the entity that's using the biosimilar, but it’s not passing on to the patient. This is different than many countries in the world in which there is a single payer, usually the government, and the government does buy the biosimilar and they are utilized quite extensively. In the UK, for instance, there are many biosimilars to etanercept as well as to adalimumab. And the cost of the biooriginal has come down because of that. It's come down significantly, but not in the United States.