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.

Videos

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. 

Peter Jørgensen: Sustainability of the Danish Biosimilars Market

So, [Biologics Price Competition and Innovation Act, BPCIA] litigation, I wouldn’t say it’s gotten any smoother. Some fundamental questions about how to interpret the statute have now been answered by the federal circuit and the Supreme Court, which certainly leaves fewer unanswered questions that can come up in a district court case.

However, these cases are still very complex. They involve many patents, many more patents than are typical in small-molecule Hatch-Waxman cases, and that has, attendant to it, further complexities in the case. There are usually more experts involved in these cases. The sheer volume of these patents just leads to more proceedings and takes longer to resolve.

And so, these cases are typically taking much longer than we saw on average in the Hatch-Waxman space. So, I wouldn’t say they’re going any smoother or less smooth, but certainly remain very complex litigations to undertake.

Alexandra Valenti, JD, associate at Goodwin, discusses how Biologics Price Competition and Innovation Act (BPCIA) litigation has evolved with greater experience.

Alexandra Valenti, JD: Experience With BPCIA Litigation

So, it is hard to manage all of the information that’s out there. Understandably, there’s a lot of different data sources and sites where you can get information, so to manage it all alone is a challenge. But there’s different information out there that talks about aspects of biosimilars, from interchangeability to extrapolation. When it’s out there, it could cause a misunderstanding about biosimilars, whether it’s intentional or not. So that’s, again, the need for education from a patient and provider level to help clarify any of those aspects with biosimilars.

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

Sonia T. Oskouei, PharmD: Biosimilars and Misinformation

I think biosimilars will be helpful. I think there’s a little doubt from a cost standpoint. I think the willingness to embrace biosimilars in the [United States] has been slower than what we’ve seen, for example, in Europe, but I think they are here to stay. Hopefully the additional competition will help to further contribute to lower drug prices, and I think it’s just going to be a matter of time before those drugs are more readily available. 

I think, though, we also have to appreciate the significance not only of the drug but of the support services that may be coming from the respective pharmaceutical manufacturers that represent a wraparound offering for the specialty drugs that they manufacture. If those programs are providing additional value, I would hope that the biosimilar manufacturers could provide something comparable to those as well. 

Bruce Sherman, MD, FCCP, FACOEM, chief medical officer of the National Alliance for Healthcare Purchaser Coalitions, discusses how biosimilars will play a role in controlling high drug costs for employers.

Bruce Sherman, MD, FCCP, FACOEM: Biosimilars and Costs for Employers

I think it’s likely that we’ll see significant proposals around patent reforms from some of the discussions that are going on at this point. I think it’s unlikely that we’ll see significant reforms anytime soon. And I say that not because I’m making a substantive decision about whether reforms are needed, but because history tells us that patent reform is slow and methodical, and I don’t expect it to be any different here.

The issue with patent reform is [that] one stakeholder’s dream reform might be a nightmare to another stakeholder. And we know from our prior iterations of patent reform that there will be many of discussions, lots of attempts to balance out interests of different parties, and especially in this Congress where there’s a lot of disagreement, I think it could be a lot of delay before we see anything significant happening in Congress. Looking to the courts is probably going to be a better opportunity for reforms that will have an impact on [Biologics Price Competition and Innovation Act, BPICA] litigation.

Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses whether the US patent system is likely to see reform in the near future.

Interviews