Biosimilars, you know, there's a lot of promise there. What we found at [Regional Cancer Care Associates, RCCA] when we looked at biosimilars is that the promise was probably more than what we'll actually see in practice. Biosimilars that take a lot of money to develop, at the end of the day, they're in the same place, many times, as the reference drug, maybe 15% to 20% cheaper.

So it's not the move you would expect from a value-based standpoint. So what I really expect we’ll see is that pricing will stabilize when you have a biosimilar because it will introduce competition, but I don't expect we'll see significant price decreases. These are not generics. So [with] a generic, the price will drop precipitously. We're not going to see that. We’ll see stabilization of price because of the competition. The more biosimilars in a particular category, the more, I think, stabilization you'll see.

So I think that's what we'll see. From our perspective, I actually just talked about our chairman this morning, and one of the things that we're looking at is, you know, how can we kind of push the value out of it? And that will be the piece that we’ll continue to kind of struggle with: how do we pull value out of that, instead of just price stability?

Videos

Terrill Jordan, chief executive officer of Regional Cancer Care Associates (RCCA), discusses how RCCA is handling biosimilar availability.

Terrill Jordan: The Promise, and the Reality, of Biosimilars

Yeah, absolutely. And we've already seen that as well. A lot of the insurance companies are starting to dictate which biosimilars we switch to and when. I think it's a great benefit to the patient as well if we can find them something that is going to do the job as well and is appropriate and payable. You know, we're interested in in pursuing that option as well for the patients.

Rhett Wilkerson, associate director of patient financial services, Florida Cancer Specialists, discusses the role biosimilars have to play in reducing patient costs. 

Rhett Wilkerson: Biosimilars and Patient Costs for Cancer Care

There has to be a practice-wide campaign for everyone in the care chain to understand biosimilars. So, when it comes to infusion nurses, they understand they're giving a different drug, but it's in the same class. And so, when we're changing drugs, we get an informed consent for these patients so they know it's a new drug. When we're starting new, the infusion nurses are just hanging them just like any other drug.

Lee Schwartzberg, MD, FACP, executive director, West Cancer Center, discusses the need for practice-wide education concerning biosimilars in cancer care.
 

Lee Schwartzberg, MD, FACP: Nurse Education on Biosimilars

Without a doubt, they'll be integrated. And I think it's funny; I gave a talk yesterday to the New York State Society of Oncology about biosimilars, and really there were 2 messages. One is, if we look back on the history of oncology, and how generics changed things, people embraced generics, and honestly, they mitigated the cost magnificently.

Now, I'm not an idiot. I understand biosimilars are different. However, the regulatory process that the FDA is put in place for biosimilars is extremely rigorous, and I think most oncologists are going to be comfortable prescribing them, and as time goes on, they’ll be more and more comfortable prescribing them.

If we look at Europe, there have been no ill effects of biosimilars and they’re 10 years ahead of us. So I think that, if you're in an alternative payment model, that is easy for you to do, it doesn't force you to confront utilization, physician practice behavior—it's easy.

Now, there's a flip side to this. Even if you don't want to do it, the payers are going to make you do it. And each payer may wind up with a different biosimilar of choice. But payers, even if they're not in a value-based care model, are going to force you to do it. There’s just no question about it.

Michael Kolodziej, MD, vice president and chief innovation officer at ADVI Health, Inc, addresses the role that biosimilars will have in alternative payment models in oncology.
 

Michael Kolodziej, MD: Biosimilars in Alternative Payment Models

The idea behind therapeutic drug monitoring, similar to many medications that utilize drug levels to target a therapeutic window of drug level to increase or improve clinical outcomes, is the same for biologic medications in inflammatory bowel disease, mostly with the monoclonal antibodies.

So there are 2 schools of thought regarding therapeutic drug monitoring and inflammatory bowel disease. There's what we call a reactive therapeutic drug monitoring strategy, and what that means is when a patient reports signs or symptoms of active inflammation, and we confirm that active inflammation, then we check the drug level, as well as the antibodies against the drug itself, to see what is the potential reason or mechanism behind this “loss of response” to these to these medications.

The other school of thought is what we call a proactive therapeutic drug monitoring strategy, and this relies on the idea that if we keep the drug in the therapeutic window in a prospective manner, meaning that we check the level on a routine basis as a patient starts the medication before they relapse or potentially display signs of loss of response, then we may improve clinical outcomes and potentially preserve some of our medications in the long run.

We're still doing a lot of research regarding these 2, but I think, generally, the more implemented is the reactive strategy at this point in time, and it's currently recommended by the American Gastroenterological Association guidelines. But I think an exciting opportunity is the proactive strategy as well.

Benjamin Click, MD, staff gastroenterologist, the Cleveland Clinic, discusses the role of therapeutic drug monitoring in treating patients with inflammatory bowel disease (IBD).
 

Benjamin Click, MD: Therapeutic Drug Monitoring in IBD 

So, the [Federal Trade Commission, FTC] and the [Department of Justice, DOJ] did an analysis following both the [Medicare Modernization Act, MMA’s] enactment of the regulatory review provision as well as the Supreme Court’s decision in 

 that held that “pay-for-delay” agreements can be subject to antitrust review.

So, FTC’s analysis showed that both of those things did result in a decrease in the number of potentially problematic settlement agreements, again in the small-molecule context, that were being submitted for review. So, in terms of whether this will affect biologics’ patent settlement agreements, I think we’ll have to see what comes of the enhanced regulatory scrutiny. And there is also an open question as to whether the reasoning of the Supreme Court’s decision in 

regarding the antitrust issue extends to biologics. And so, it’s kind of a wait and see, I think.

Alexandra Valenti, JD, partner at Goodwin, discusses whether drug makers are given pause by the possibility of regulatory scrutiny of patent settlements. 

Alexandra Valenti, JD: Regulatory Scrutiny and Biosimilar Settlements

I think continuing to try to make it efficient for biosimilars to get claims of interchangeability will help make the products ultimately more competitive. That process, doing the switching studies to get an interchangeability claim, is fairly efficient, but I think there’s things that you can continue to look at in terms of using real-world evidence and looking at how you structure those switching studies to potentially make it more efficient.

Sometimes those studies are hard to enroll because doctors don't want to enroll patients and patients don't want to enroll in those kinds of studies. So, we do need to continue to look at that, but again, I don’t think that is the biggest impediment if you will, or is going to provide the biggest benefit in terms of trying to foster more competition. I think that the greatest changes that we can make are really going to be on the commercial side.

Scott Gottlieb, MD, former commissioner of the FDA, discusses how to improve the US biosimilars market.

Scott Gottlieb, MD: Improving the US Biosimilars Market

Yes, I think regulatory agencies have a real leadership role to play. They’re, you know, the referee. The government, the FDA, is here to serve the citizens and support effective and safe care. And there is also a role in affordable care, so providing some guidance in terms of efficacy and safety will help pave the way to affordable care. So the FDA has also changed; I think they’re much more responsive to what’s happening. I think they’re a key partner and playing a significant role as we improve care.

Nicholas Robert, MD, medical director of data, evidence and insights at McKesson Life Sciences, discusses the FDA’s role in helping providers become comfortable with biosimilars. 

Nicholas Robert, MD: The FDA and Education on Biosimilars

So, the FDA has released guidance indicating that insulin and other products that, for historical reasons, were previously regulated as small molecules will be transitioned to be regulated as biologics. And, this raises a couple issues for drug manufacturers.

One is that if you submit an application for, let’s say insulin, ahead of the transition date in March of 2020 and the application is not yet approved as of March 23, 2020, your application would need to be resubmitted under what will be the new framework for that product under the biologics regulatory framework.

So, that creates this period that we’re in right now, really, where companies probably won’t be filing applications on these products because there’s that risk of not being approved in time and then having to restart the whole process. So, it just makes more sense to wait until March 2020, basically, to go ahead and submit the application.

The other issue is if those new applications do have to get filed, what are the consequences of that? Does it reinitiate patent dance procedures under the [Biologics Price Competition and Innovation Act, BPCIA]? Other kind of regulatory issues having to do with the new application that you would need to submit, and so we do have this situation now where there is sort of a disincentive to go ahead and file applications on these molecules because there is so much uncertainty about what happens on the transition date if I’m under development as it stands now.

Alexandra Valenti, JD, partner at Goodwin, discusses what drug makers should consider as the United States approaches a regulatory transition for insulins.

Alexandra Valenti, JD: The 2020 Transition of Insulins to Regulation as Biologics

I think Congress struck the right balance. I think that Congress gave enough flexibility to the regulatory authorities, including FDA, to try to continue to evolve the biosimilar pathway.

I think in terms of the data protection that was provided, it was the right balance to create incentives to continue to invest and innovate while still creating an entry point for lower-cost competition.

I think that the challenge now is continued regulatory improvement to try to make the process more efficient and lower cost so you see more entrants and maybe get the cost down developing a biosimilar, but also looking at some of the commercial challenges and the reasons why we don’t see fast ramps, and we don’t see as much physician adoption as we probably should given the rigorous process that these products go through and the value that they have the potential to deliver.

Scott Gottlieb, MD, former commissioner of the FDA, discusses whether Congress should make changes to the Biologics Price Competition and Innovation Act (BPCIA) if the opportunity arises. 

Interviews