Impact of Competition of Biosimilars on Biologics

Considerations of biosimilars as a valuable asset to the health care system, the impact of the competition biosimilars have on biologics regarding price and rebates, and final thoughts.

Anthony Mato, MD, MSCE: Let’s talk about biosimilars and asset. Marc, why don’t you try to tackle this question. Do you consider a biosimilar to be a valuable asset? How do you value them?

Marc Earl, PharmD, BCOP: It’s a great question, and with everything we’ve talked about today, I definitely think they’re a valuable asset. The cost of drugs is increasing exponentially. We’re looking for ways to decrease that cost and maintain quality. These are a perfect example to have the same efficacy, same safety, and potentially have 10%, 20%, 30% reductions in cost.

Our institution is a part of a model called the Oncology Care Model, which is through Medicare. The goal is to reduce cost compared with your prior years and maintain high quality. This is a great example of a project that brings a lot of value in a program like that. I do think they’re very valuable. To the points that Bhavesh made about driving down some of those reference prices that continue to increase, it’s very valuable.

Anthony Mato, MD, MSCE: Any other comments? I’m torn at times when thinking about which studies to bring for my patients when so much of a focus is innovation—how to fit and utilize resources to help develop biosimilars, which are always at the cost of not having studies that may advance the field in other ways. So I’m torn about how to value biosimilars as an asset from the perspective of clinical research. You may someday be part of a program that’s developing a daratumumab biosimilar, and the choice would be to develop that versus another drug within the field. We have to make these decisions all the time, and it’s not easy to make that decision.

Tim Peterson, PharmD, BCOP: Right, and it’s definitely a difficult decision, but I think it’s very clear that these biosimilars are a valuable asset to the health care system. As Bhavesh has discussed, the cost of these biosimilar agents is on the order of 15% to 25% less. While these don’t directly translate to the patient yet, I think with changes and payer structure, they likely will see these downstream effects in coming years with more adoption of the biosimilar agents. As we see more biosimilars for a specific referenced product, that’s going to drive down the competition, the cost of the referenced product and of those additional biosimilar agents as well.

Marc Earl, PharmD, BCOP: The 1 thing I’ll bring up on the patient side is that we have a fair amount of folks who pay a co-pay as a percentage of the drug charge for when they receive it. As that cost goes down, they are going to pay less. I think it’s hard when you’re sitting with the patient to tell them exactly how much less it is going to be for them. But their co-pay is going to be less as a part of that drug cost and biosimilar perspective.

Anthony Mato, MD, MSCE: Anybody want to talk about rebates and how biosimilars might impact that?

Tim Peterson, PharmD, BCOP: The so-called rebate trap—I believe that is what they call it. When a biosimilar comes out to a referenced product, the referenced product does everything it can to try to maintain market share. First, we have to have the patent litigations that go on for months to years. But then they can do something like giving rebates to payers to try to entice them to maintain the referenced product and potentially trying to entice formularies to keep them on the formulary, to continue using the referenced product. That tries to reduce the benefit of the cost savings of the biosimilar agents. If they’re not able to have the generic drug cost savings of 75% to 80%, and they’re just in that 15%-to-20% range, that gives the referenced product potentially a little more wiggle room to do those types of rebates and maintain a little more of the market share.

Bhavesh Shah, RPh, BCOP: There was actually a very public editorial from Scott Gottlieb in the Wall Street Journal that talked about how the government does need to regulate the rebates, which are actually the main reason why there’s a significant decrease in the adoption of biosimilars.

Anthony Mato, MD, MSCE: This has really been a great conversation. I’ve learned a lot from everybody. Before we conclude, I would like to get final thoughts from each of our panelists, and maybe we’ll go across and start with Marc. Final thoughts on biosimilars? What’s the 1 message you want to give our audience?

Marc Earl, PharmD, BCOP: Looking at the science, really knowing that as a health care professional—and knowing what the FDA is looking at and how rigorous that process is— in the end is going to be the most important piece. If you understand that, you can help explain it to your nursing teams, your physician teams, and your patients. I do believe it can bring down drug cost for what’s a really expensive therapeutic area right now.

Anthony Mato, MD, MSCE: Bhavesh?

Bhavesh Shah, RPh, BCOP: I think 2020 is probably an exciting time for biosimilars because we have 3 major biosimilars in oncology that are going to significantly bring down the cost of cancer care, and we know there is a significant nonadherence to therapies for patients with cancer because of high co-pays and high cost. There’s a huge potential, and there’s a lot of excitement around adoption of oncology biosimilars to bring down the total cost of care.

Anthony Mato, MD, MSCE: You have the final word for our panel, Tim.

Tim Peterson, PharmD, BCOP: I agree with both of these gentlemen that the introduction of these biosimilars is meeting an unmet need. We know that the high costs of medicine right now are exponentially increasing, and it’s taking the access of care away from many patients. Many of these medications are potentially lifesaving and life prolonging.

As we have these biosimilars that become more involved in clinical practice, we’ll see more patients who are able to obtain these therapies and prolong life, and we’ll see better responses. It is important to have a firm understanding of the developmental process so you can explain that to providers, who can explain it to the nursing team, and who can explain to patients if they need it to be explained to them.

It’s important to also understand the extrapolation of indications and the reasoning for those things to be able to actually fulfill the point of a biosimilar development program, which is to bring these medications to patients who can’t obtain them and can’t pay for them.

Anthony Mato, MD, MSCE: That’s a great final point. Well, on behalf of our expert panel, we hope you found this Peer Exchange® discussion to be useful and informative. Thank you for paying attention.