Yes, so I think biosimilars have the opportunity to potentially change the biologic landscape. Biosimilars are just starting to come into routine clinical practice in the United States. They’ve been used for several more years in European and non-American countries, so a lot of the more long-term experience coming from the European colleagues is very encouraging.

We are starting to routinely use biosimilars, mostly for infliximab at this point in time, though we do hope to see a biosimilar for adalimumab hit the market in the next several years. So I think there’s a lot of potential cost savings opportunity when we think about healthcare costs in the United States and how we can potentially impact those as well.

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Benjamin Click, MD, staff gastroenterologist, the Cleveland Clinic, discusses how biosimilars fit in the treatment paradigm for inflammatory bowel disease (IBD). 
 

Benjamin Click, MD: Biosimilars in IBD

For biosimilars, outcomes-base contracting may be very important in terms of guarantees for certain health outcomes, like a measure of response of the patient. So that could be certainly something in a broad understanding of value that’s very interesting, so it could certainly apply to biosimilars as well.

Jonathan Campbell, PhD, associate professor, Department of Clinical Pharmacy, Pharmaceutical Outcomes Research, Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado, discusses whether value-based contracts have a role to play in biosimilar uptake. 

Jonathan Campbell, PhD: Value-Based Contracts and Biosimilars

We’ll see what the courts ultimately do. I’m pretty confident that Congress would continue to authorize the biosimilar pathway, and if for some reason the Affordable Care Act was struck—which doesn’t seem likely&mdash;but if for some reason it was struck, I think Congress would come back in and quickly reauthorize the biosimilar pathway.

Scott Gottlieb, MD, former commissioner of the FDA, discusses what might become of the Biologics Price Competition and Innovation Act (BPCIA) if the Affordable Care Act (ACA) is invalidated. 

Scott Gottlieb, MD: The ACA and the BPCIA

So in terms of adoption, anything new faces some resistance. It depends on the impact. In conversation with my physician colleagues, supportive care is less of a hill to climb over, so to speak. When you start replacing drugs that have impact on therapeutic outcomes, physicians are cautious. I think people will be cautious. But I think the data to date certainly supports that there is certainly reason to adopt biosimilars in the therapeutic realm, so I suspect it’s going to happen. To be frank, there is an economic piece as well. If it’s a more attractive option, I think everyone is aware about the cost of healthcare, and certainly people think that biosimilars are one way to attack that problem. And I think, frankly, everyone involved is onboard to reduce healthcare costs.

Nicholas Robert, MD, medical director of data, evidence and insights at McKesson Life Sciences, discusses how comfortable oncologists are with using biosimilars.

Nicholas Robert, MD: Oncologists' Comfort Level With Biosimilars  

So, the cases typically allege antitrust violations based on 2 features of what’s happened with AbbVie’s Humira adalimumab product. The first is AbbVie’s acquiring a very large patent estate covering that product. Well over 100 patents covering the 1 product. There’s allegations that those patents are very similar to each other, have overlapping claims, and lead to a kind of improper monopoly over the adalimumab Humira product.

The other piece is the settlement agreements that we’ve mentioned a couple of times already. AbbVie has settled with 8 different biosimilar manufacturers concerning their adalimumab products. And under those agreements, most of those products are already available in the European Market but won’t enter the US market until a staggered set of dates in 2023, and so the antitrust allegations are based on that state of affairs, alleging that AbbVie has improperly kind of orchestrated the biosimilar competition and staged it in such a way that biosimilar competition won’t enter the market until much [later] than it would have otherwise.

Alexandra Valenti, JD, associate at Goodwin, discusses common features of some recent high-profile class-action lawsuits over AbbVie’s Humira. 

Alexandra Valenti, JD: Common Features of Lawsuits Filed Against AbbVie Over Humira

Well, the process for developing a biosimilar and getting it through the development process is fairly efficient. It’s costly—biosimilar manufacturers will say it will cost anywhere from $100 million to $300 million to develop a biosimilar. A lot of those costs aren’t necessarily the clinical trials, but the cost of actually developing the biosimilar. It’s not a trivial process. The manufacturing cost is substantial. You have to make a big investment in manufacturing when it comes to a biologic.

I think there are ways to continue to make the development process more efficient, in terms of the kind of clinical information that’s required through the regulatory process. I don’t think you’d ever eliminate it. I think there’s always going to be a need to do some level of clinical evaluation and have some component of clinical trials in order to prove the similarity or sameness of the biosimilar to the incumbent biologic, but I think that there are ways to continue to make that process more efficient.

But once again, I don’t think that toggle isn’t going to dramatically change the value proposition and the opportunities when it comes to biosimilars. I think where we’re going to have the most ability to try to move the needle, when it comes to biosimilar adoption, is more on the commercial side.

Physician adoption, physician acceptance, educating doctors about biosimilars, looking at some of the structures in the market that create impediments to biosimilars launching into the market effectively, like the existence of rebates on the incumbent biologic.

Scott Gottlieb, MD, former commissioner of the FDA, discusses whether phase 3 trials for biosimilars might eventually be waived in the United States.

Scott Gottlieb, MD: Phase 3 Trials and Biosimilars

The other thing to add is probably the knowledge-sharing between practitioners with those who have used biosimilars already. I think, a lot of times, people are waiting to see how their peers have utilized the product, how successful they’ve been. So having that real-world evidence and best-practice sharing is going to help a lot as well.

Sonia T. Oskouei, PharmD, vice president of innovation and solution development at Premier Inc, discusses ways to increase provider comfort with biosimilars.

Sonia T. Oskouei, PharmD: Knowledge-Sharing and Biosimilars

The FDA has some power to regulate communications about biosimilars that might be made by branded companies, and they get that power from their power to regulate advertising in this space. We’ve seen citizen petition by folks like Pfizer asking FDA to get involved in managing the communications around the safety and efficacy of biosimilars. Hard to tell yet what FDA will do about that.

We know from the legislative fight around the [Biologics Price Competition and Innovation Act, BPCIA] that FDA really wants to stay out of litigation, and it may be the case of what we end up with seeing is the [Federal Trade Commission, FTC] or the [Department of Justice, DOJ] getting involved as we’ve seen in the Hatch-Waxman space, where there are examples of companies who have made significant misrepresentations about their product versus prior products or generic versions of their product, and have seen themselves faced with numerous litigations filed by a state attorney general, the FTC, the DOJ, the plaintiff’s bar, and competitors and the like. We may see that before we see FDA do much. 

Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses what power the FDA has to regulate communications about biosimilars made by innovator drug companies.

Elaine Blais, JD: The FDA and Communications About Biosimilars

Well, I think a lot of the challenges with biosimilars weren’t necessarily related to the regulatory process. Certainly, trying to make it lower cost to enter the market, make it more efficient to get claims of interchangeability, or to extrapolate across different indications for biosimilars that were in biosimilar launches, they can launch with the full suite of indication that the reference product had. That’s all going to help facilitate I think a more competitive market, but a lot of the challenges were on the reimbursement side—on the coverage side&mdash;where it was hard for a biosimilar to enter the market.

I think one of the challenges was physician adoption—there was reluctance amongst physicians to adopt biosimilars. I don’t think that was unexpected. If you look back at the early days of Hatch-Waxman, there was a lot of physician reluctance to adopt small molecule generic drugs because of a perception that they weren’t the same as the branded drug. Eventually, physicians got comfortable with generic drugs and understood that they were just as safe and effective as the branded counterpart. I think we’re seeing the same evolution with biosimilars; it’s actually happening more quickly with biosimilars.

Another impediment is the rebates that exist on the incumbent biologic in some cases create an impediment to the biosimilar launching into the market. One thing we might look at is whether or not there should be rebates allowed on branded biologics once a biosimilar enters the market. So, we talked about doing away with the safe harbor for rebates in the context of all drugs in Medicare Part D. There was a rulemaking process to look at whether or not Medicare should basically eliminate the safe harbor from manufacturers to negotiate these rebate agreements with [pharmacy benefit managers, PBMs].

That ultimately didn’t go forward, as we saw in the press recently, but one place where we might reconsider reintroducing that concept, in doing away with the safe harbor for rebating, is in settings of the biologics when a biosimilar enters the market, because you could make an argument that in the setting of a market where there is an incumbent biologic, and there’s a new biosimilar entrant, the existence of a rebate, or the ability to rebate off of the incumbent biologic, truly is anticompetitive in that setting. So, we might look at narrowly tailoring that policy just for that specific setting.

Scott Gottlieb, MD, former commissioner of the FDA, discusses which policy changes would have the greatest impact on the US biosimilars market.

Scott Gottlieb, MD: Policy Changes and Biosimilars

I don’t think there will be the drastic cost reduction that some people are hoping for that we see with some drugs, because it is complicated to make some of the biologics, to make the monoclonal antibodies. But I do think that will create some price pressure, that’ll create some alternatives.

On the flip side, I think one thing that often happens in that setting, it does motivate scientists, pharma, biotech, to come up with even better therapies. So hopefully, it’ll be a win-win solution: decreasing financial toxicity on one hand, and leading to even better therapies on the other.

Howard Burris, MD, FACP, FASCO, president of clinical operations and chief medical officer of Sarah Cannon Research Institute, discusses how oncology biosimilars will impact financial toxicity.

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