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.

Videos

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.

Howard Burris, MD, FACP, FASCO: How Oncology Biosimilars Will Impact Costs

So recently, Coherus did sue Amgen on patents it has on an adalimumab formulation. Both companies in the litigation are biosimilar manufacturers, so it’s a little bit atypical from our average [Biologics Price Competition and Innovation Act, BPCIA] litigation where the plaintiff in the suit is the branded biologic manufacturer.

The suit is interesting from a strategic standpoint because Coherus is one of the settling adalimumab manufacturers along with Amgen. And under those settlement agreements, Amgen is set to be the first adalimumab biosimilar launch in the United States in January of 2023. Coherus won’t launch until December 2023 under its agreement, and so the suit presents and interesting scenario because all Coherus can really hope to achieve is to keep 1 of 7 potential biosimilar competitors off the market, that being Amgen, if it is successful in the suit. Amgen again, being the first to launch. And so, it is an interesting case from that perspective to understand what Coherus is hoping to achieve with the suit.

In terms of whether we think this is going to be a trend that will continue, there are certainly experiences from the small molecule Hatch-Waxman litigation space where there were generic versus generic suits. But, many of those suits weren’t successful. Of the suits that I and my colleagues are aware of, none resulted in a finding of infringement. And so, none resulted in a ruling that would have kept one of the generics off of the market.

And so, I think it’s reasonable to assume that we will see more biosimilar versus biosimilar cases. Biosimilars by their nature do not have to match the biologic to the extent that a small molecule will, and so it does open up, due to the complexity of the molecules, opportunities for biosimilar manufacturers to pursue patents on processes, different formulations, and other aspects of their products that may not already be patented by the biologic. So, I think we will see more of these suits, and the question will be how successful will they be and what will their effects be on the market landscape.

Alexandra Valenti, JD, associate at Goodwin, discusses a recent case in which one biosimilar developer sued another over adalimumab.

Alexandra Valenti, JD: Biosimilar Versus Biosimilar Suits

I think it needs to be multifacted for multistakeholder education, and it needs to come from different areas. I think the FDA did a great job of releasing the whole biosimilar educational campaign, but if it’s not being utilized, it’s just sitting there, then we’re not leveraging those resources. So it’s being proactive again with the education, utilizing what’s out there, working with different societies and foundations to have that information embedded in the education as well is very important.

Sonia T. Oskouei, PharmD, vice president of innovation and solution development at Premier Inc, discusses biosimilar education.

Sonia T. Oskouei, PharmD: Biosimilar Education

In terms of my specialty, which is rheumatology, I think rheumatology pharmacists and rheumatologists have actually led the way in adopting biosimilars, only because we’ve had so much experience with biosimilars compared with dermatologists and gastroenterologists. So I think the rheumatologists have really led the way in providing that real-world evidence, that confidence, that transferrable data.

Kalveer Flora, MPharm, London North West University Healthcare National Health Service Trust, explains how rheumatology specialists have led the way in biosimilar adoption. 

Kalveer Flora, MPharm: Experience With Biosimilars in Rheumatology

So the biosimilars, I think, will be rapidly adopted. We’re in a world where the new cancer drugs really sort of came along in a flood in the 1990s, so we’ve had experience with generics in that regard. We’ve had oral generics coming along for a while. I think the biosimilars are actually coming from some of the larger manufacturers. The idea of transitioning to that, I think, will flow well.

Howard Burris, MD, FACP, FASCO, president of clinical operations and chief medical officer of Sarah Cannon Research Institute, discusses the adoption of oncology biosimilars.

Howard Burris, MD, FACP, FASCO: Adoption of Anticancer Biosimilars

As we know, the [National Health Service, NHS] is always in the news as being cash-strapped. The demand is so high, whereas the resources we have are so low. So if we know that we can save money by using a drug that’s just as efficacious and works just as well as a more expensive drug, it’s so beneficial for the NHS to use a more cost-effective drug.

This has been seen through using etanercept, rituximab, and adalimumab biosimilars. The NHS has been able to save a pot of money which they can use for more expensive treatments with cancer. We know now that, in the UK, [National Institute for Health and Care Excellence, NICE], which is a regulator that approves medicines for us, has now approved CAR-T therapy, which is a new drug therapy which is very expensive, and we’ve only been able to do that through biosimilar savings.

So it’s using savings from biosimilars to use in cancer, multiple sclerosis, migraine treatments, and that’s the way forward now.

Kalveer Flora, MPharm, London North West University Healthcare National Health Service (NHS) Trust, discusses how biosimilar savings have been put to use by the NHS.

Kalveer Flora, MPharm: Biosimilar Savings and the NHS

Whenever you have something that is really a huge success, you always pause for a second and think, “Can this really continue? Where are the clouds from the horizon?” Now, with the introduction of the first 4 blockbusters in Denmark, where we have replaced them completely with biosimilars, we have saved 6%, 7%, 8% of the total Danish hospital budget with 4 products. 

But as we all know, there are not that many more blockbusters just around the corner. When you come to smaller biologic medicines, smaller products, if you will, of course you can still save money, but the interest may not be quite the same. The key here to continue to save a lot of money is that you have enough players in the Danish area. We have a tender system in Denmark, which is very efficient in keeping down prices. 

But we also know that, if you have a system that keeps down prices, then companies might think twice about whether they want to be on the Danish market. Denmark is less than 6 million inhabitants. Just take Germany, which is just around the corner. We have a common border with the Germans. They are about 80 million people. So it’s a much larger market. You could be concerned, will pharmaceutical companies stay on the Danish market when prices are that low?

Maybe, to be quite honest, the uptake has been a little bit too high, a little bit too quickly, and the rebates have been a little bit too high as well. Because what we want to have is not just success now, but we want to have success also for the future, for the good of the patients, for the good of the economy. In order to do that, you need to create a sustainable market in the long run, and I’m not quite convinced we are there yet. But it has certainly been a good start. 

Peter Jørgensen, director of the Industrial Association for Generic and Biosimilar Medicines, Denmark, discusses whether the Danish biosimilars market is sustainable. 

Interviews