The Future of Biosimilars and Managing Inflammatory Diseases

Peter L. Salgo, MD: Going forward, looking at probable future approvals of new biosimilars, is this going to change the way diseases are managed in the United States?

Vibeke Strand, MD: I really wonder. I would like to have the feeling that, yes, patients will have more access to these more expensive biologic products which, by and large, are more effective. But, in fact, we already know that there’s still a lot of innovation—there are still a lot of new products coming along. And, for instance, in rheumatoid arthritis (RA) and psoriatic arthritis and spondyloarthropathy, we’re starting to have, also, new synthetics being developed. Now, are they going to come out to be less expensive than a biologic? So far, it’s somewhat less expensive but, still, in many of our minds, overpriced. So, I’m not sure, looking forward, how much biosimilars are really going to make a difference in either the way we manage our patients or even in the fact that we would like to diagnose them earlier.

Peter L. Salgo, MD: All right. You sort of answered where I was going to go to sum this all up. In regard to the treatment of RA, ulcerative colitis, and my least favorite disease on the planet, Crohn’s disease, looking forward, we’ve got biosimilars, we’ve got biologics, and we’ve got your new drugs in the pipeline that may not be these drugs. Where do you see the treatment of all these diseases going?

Allan Gibofsky, MD: Putting aside the biosimilar situations, I think we’re going to see much more of an effort in personalized medicine in treating the patient as an individual rather than as part of a cohort. And in trying to define the unique factors, that will allow us to prescribe a given therapeutic to a given patient (rather than selecting something based on how it worked in the population). I think that’s the next step.

Vibeke Strand, MD: I’m really excited by the fact that even though the United States FDA (Food and Drug Administration) seems to think that there’s not an unmet need in RA, we don’t have any cures, but we have 11 or 12 very effective products. We’re still seeing new innovation—new classes of products—and that’s exciting to me. And that’s also stretched into all the other indications in rheumatology, and I know that you feel the same way, Gary.

Gary R. Lichtenstein, MD: Yes. We’ve looked a lot at the microbiome because it might contribute, as well. And this is huge in the area of inflammatory bowel disease combined with the genetics and in looking at microbiome signatures—looking at response to therapeutics. The key is “precision medicine.” Can we predict who will and won’t respond? We’re getting there. We can predict future prognosis. We’re now developing equations that you can plug in, if you would. You can plug in and say, “This is the natural history that will occur without medication and with medication.” We’re getting the databases from the larger studies and are trying to individualize patient prognoses based on risk factors that we recognize.

Peter L. Salgo, MD: It reminds me of a story back at the turn of the 19th to the 20th century. I think it was Rutherford, a famous physicist, who said, “I think we’ve got this all worked out.” We pretty much understand physics. There is not a lot left to discover. And then along came Einstein and the quantum mechanics, and all heck broke loose. This is an exciting time to be in medicine. What a great discussion. What I’d like to do, before we go, is give each of you an opportunity to share one last word for our audience. Dr Gibofsky, why don’t you start?

Allan Gibofsky, MD: With regard to the topic we’ve been talking about the last hour or so, I think biosimilars are an important innovation in our therapeutic armamentarium. I think they have the real potential for lowering costs to the system and possibly increasing resources for patients and increasing their access. I think we still need some of that evidence to accrue before we’re fully comfortable, but I do think that the ability to use these drugs more widely will be a significant advantage in the treatment of the chronic inflammatory diseases we’ve been talking about.

Peter L. Salgo, MD: Dr Lichtenstein?

Gary R. Lichtenstein, MD: Similar to what was stated, I think the issue is that many patients are treated poorly. We recognize this in specialty centers, whether it be in the community or academic medical centers. They don’t get the appropriate therapy that they rightfully deserve, and diseases progress. And, in an effort to contain that, I think earlier, appropriately aggressive treatment is something that we truly should be striving for. And an effort to do that, the addition of biosimilars to our medical armamentarium, is truly something that will hopefully help us achieve that.

We have several areas we’re not yet as knowledgeable on that we will be in the future. If we come back a year from now, I’m sure we’ll say differently. In regard to the nonmedical switching, we have some good initial data, but the multiple switches is really the concern, and we, hopefully, will gain a better understanding as to whether that is or is not an issue.

Peter L. Salgo, MD: Dr Strand?

Vibeke Strand, MD: I think one of the interesting things is that, by and large, most of us took biologics for granted. OK, they were parenterally administered, but you simply write for it, and then you get the injectable and you use it. Now, I think with biosimilars and so on, we’re thinking about, “Well, how are they manufactured, and why might there be some differences (even between a reference product), and how is that relevant to understanding biosimilars?”

In general, I think we’re learning a lot more about the biologic products, and that translates also into learning how we might have better precision medicine—how there might be individual variability and what the appropriate therapy is for a patient. We’re still just cracking that nut, but I think it’s one of the things to look forward to.

Peter L. Salgo, MD: And Dr Wilson, you get the last word.

Cole Wilson, PharmD: I’ll just echo what the panel is saying—the opportunities with biosimilars are great. They’re great from a patient choice, they’re great for provider choice, and they can have a lot of cost savings and opportunities. I think the future will tell a lot of the litigations and the limitations. The access channels of some of these (that first come to market) will really pave the way for the future of biosimilars and how we use them in our practice. I don’t know if it was recorded, but years ago, when generics came out for branded traditional products (I don’t know if it was taped), I think similar discussions and angst were around these products. And so, we might be looking back 10 years from now in disbelief that we even had these conversations around biosimilars.

Peter L. Salgo, MD: The comment that you might hear is “What was the big deal?”

Cole Wilson, PharmD: Right, exactly.

Peter L. Salgo, MD: But right now, it’s fascinating stuff.

Cole Wilson, PharmD: It is.

Peter L. Salgo, MD: It’s a good time to be a doctor and, by extension, I suspect it’s a good time to be a patient.

I want to thank all of you for being here. It’s been a tremendously useful and fascinating discussion for me. On behalf of the panel, I want to thank all of you for joining us, and I hope that you found this Peer Exchange^® to be useful and informative. I’m Dr Peter Salgo. I’ll see you next time.