In terms of the policy environment, in the last few months we've seen some big shifts, right? So Medicare Part B was a pretty significant concern for us with shared J-codes, because you weren't able to really manage that average selling price. So now that we have the legislation and the regulations that were changed where every biosimilar will have its own J-code, that certainly has made it a lot easier.

But it hasn't made it easier than the reference product for us. So I kind of feel like we're on a level playing field, whereas we weren't before, but I would argue that maybe we actually need to move beyond a level playing field in order to facilitate this uptake.

The second area is Medicare Part D. We had a significant issue where we were actually by law prevented from supporting patients through the doughnut hole where now that got changed in the budget changes at the end of January. And so we're certainly excited about that opportunity, but at the same time we're just on a level playing field, and we haven't yet been really enabled to be facilitated, I guess, that true uptake, and I think that's where the benefit is.

Now, at the same time, if you listen to Scott Gottlieb, he's talking about pretty significant policy reforms that we know they're looking at and that we continue to work with them on. I do think that there's kind of 2 issues.

There's a patient and a market confidence issue as we bring these products to market. There is the patent situation, and then finally there's the rebate wall. So, when you're going up against these massive products, I think it's really incumbent on the biosimilar companies to try to really deeply understand how we can work better within the system from a contracting perspective, and transparency, in order to really make that uptake happen much more quickly.

So, when you compare the US market to the rest of the world, everybody's going like, "What's taking you guys so long?" Right? So, what is taking us so long?

There are some disincentives, for sure, in the current structure of the system. At the same time, I couldn't be more excited about the amount of energy around trying to make this happen in order to make sure that our system is sustainable. It's critical for the future of the [United States] to make sure that we have a sustainable healthcare system.

Videos

Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses policy challenges related to biosimilars.

Sheila Frame: Biosimilars and the Policy Environment

I think device design is a super exciting area for innovation that biosimilars can actually bring to the marketplace, so especially for Sandoz, because we're part of a larger organization, we have access to some tremendous device technology that we can bring into the marketplace with already having had the experience, right? It's not like we have to start from scratch to create that innovation in terms of device, but we can actually benefit from all the innovation that's happened in the past from other manufacturers and bring that into our biologic products to make sure that patients get exactly what's easy.

I do think it's important. I think there's a big stigma associated with either sitting in an infusion chair for hours or sticking yourself with a needle every day. We see it in diabetes, right?  You see it in arthritis now, and there's been some tremendous innovation in terms of those devices. So I think it's a pretty exciting area for us and certainly one that we're always looking for new and better ways to make it easier for patients to not only access their medication, pay for them, and also benefit from the innovations in terms of making it simple.

Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses the importance of device design for biosimilars.

Sheila Frame: Biosimilars and Device Design

Are there gaps in knowledge about biosimilars that are impacting decision-making by stakeholders?

I think we’re not seeing the utilization because there’s not a lot marketed yet, so it’s tough to see what’s happening out there in the marketplace after you get real-world use of these products. From a standpoint of the approvals and the trials, you know they’re of course safe and effective from the standpoint of being biosimilars. The other piece of it is there may be some concerns about safety and the immunogenicity, but I don’t believe that’s having a significant impact on the use currently. It’s really just the amount that are available for use. Also, again, because there’s not a lot of competition in the marketplace, the ability to see significant cost-reductions that is hoped by these therapies has not yet been reached.

Mark Cziraky, PharmD, CLS, vice president of research for Healthcore, explains why biosimilar utilization in the United States is low.

Mark Cziraky, PharmD, CLS: Biosimilar Utilization

Well I think one of the biggest challenges is the level of—the number of biosimilars that are being approved in the market. I mean, we’re seeing 10 now [approved] to date* and we’re going to see another 10 hopefully this year; a total of 20. But comparable to Europe, there’s 41 now approved ex-US, so we have a lot of room to catch up. In addition to that, the actual marketing of the products is a lot slower than was anticipated, so, with those that are already approved, only 3 are currently available on the market. So, the amount of market penetration, the amount of cost reduction that we’re able to see currently with those therapies is quite limited.

Mark Cziraky, PharmD, CLS, vice president of research for Healthcore, describes challenges in the US biosimilars market. 

Mark Cziraky, PharmD, CLS: Challenges in the US Biosimilars Market

Well, it's an immediate opportunity for cost savings. I think from a contracting perspective, as we come into the marketplace, the minute any organization chooses a biosimilar as either a first-line treatment or a second-line treatment or converts from the originator product, then the patient should be seeing those savings immediately.

But, as you know in the US marketplace, transparency isn't necessarily something that everybody's able to get to, right? We can see it, because we contract directly, but the way the US system evolved over time, for lots of good reasons, there's so many people in the middle where the product actually goes through these middlemen, then everyone kind of takes their share. By the time it gets to the patient, it's a $25 copay or it's a $50 copay or it's a deductible.

So I believe that the more transparency that we can bring to the system overall, then the sooner patients are going to see the value and benefit from it.

So, because we have this great evidence now to suggest that biosimilars are just as good from an efficacy and safety perspective, then I think patients are going to be willing to take them on and say, hey, I want to make sure that I get access and that I get access at a fair price and that the system benefits from these products once they're available.

Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses when patients will see their costs reduced as a result of biosimilars. 

Sheila Frame: Biosimilars and Cost Reductions for Patients

So in terms of access, I think we have great data now from Europe to show the number of additional patients who get treated. I think people will say to you, hey, Americans, generally speaking, have pretty good access compared to another country where it might be a single-payer system where they rely much more heavily on supply constraints, in the United States typically we don’t have supply constraints, because it's a copay, right?

So the patient doesn't know exactly what the cost of the medication is or what their coverage is or whatever. They just have a copay. I think though, increasingly, as we get more and more transparency in the system and you've heard now some of our big insurers and big pharmacy benefit managers are now actually saying, hey, we're actually willing to share the savings with patients directly, with providers who are infusing these products.

I think that there's a question mark in the United States as to how much more access we'll get, but I do believe, with the number of people who may not have great coverage, that they will now potentially be able to access these products. And I think that's exciting. I really do. I think it'll benefit society.

You know, when I think about rheumatoid arthritis, how many people do you see today who have been crippled by rheumatoid arthritis? Not so many, right? Because of biologics and the value they bring. And I think we probably all can imagine, whether it's a grandmother or a great aunt or whatever who had serious debilitating [disease], lived with pain, all of that kind of thing. The earlier you treat with biologics, then the less and less we've seen from that. So they're incredible innovations, and you don't want anybody to have to go through that if they don't have to.

So I think that's the opportunity from an access perspective. Now, we have great evidence in Europe where there's lots of people who otherwise wouldn't have had access, were treated for years on less expensive medications who then were able to get to biologics because of biosimilars. I think we all have that hope for the United States as well.

Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses how biosimilars can increase patient access to treatment.

Sheila Frame: Biosimilars and Patient Access

Are there some specific reforms in patents that you would like to see the United States implement to help encourage competition in drug pricing? 

One of the key areas that I think needs to be improved upon is the standard of what is patentable. I feel the law has not kept up with the advances with how [research and development, R&D] is done, and how scientific knowledge has been accumulated over the last 50 years. Unfortunately, in order to get your patent, you’re judged by whether it’s novel, based on what’s known in the field, or if it is obvious to someone in the field.

The obviousness standard is not applied in the correct way. It’s almost as if techniques from 50 years ago are still not obvious to people, and I think the law hasn’t kept up.

One of things my organization and other organizations has talked about is bringing that standard up to where science is today, and we’ll find that a lot of things are obvious. Patents would not be granted so readily, and only the really high-end inventions would be. That’s where a lot of the focus needs to be on, unfortunately the court systems are in this old sort of thinking, “Oh it’s what it was 20 [or] 30 years ago.”

I think the other area is we need more public participation in the patent system, the public actor or patient group cannot challenge a case in court unless its infringing the actual product in question. Which means, therefore, only commercial actors have the right to challenge a patent. Which is why the 

 case is important, because that forum allows any person—any public person or a group like ours can go in there without infringing. Getting rid of this would be catastrophic, because it means only the rich get to play in a rich playground. 

Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses reforming the patent system.

Tahir Amin: Reforming the Patent System

What have we learned from Allergan’s transfer of patents to a sovereign tribe about patents in the United States?

Thankfully we’ve learned that the courts struck it down. They saw it for what it was, there was a decision in Texas where the judge called it for what it was, then the PTAB also said no, these [inter partes review, IPRs] will go ahead. Thankfully, we saw sense that a maneuver by Allergan to actually avoid its patents from being challenged was avoided.

Unfortunately, I think that’s just the tip of the iceberg. Companies have a whole toolbox of strategies and tricks that they use, and unfortunately, in a way they’ve undermined what the patent system was originally intended for. Now they use it for a defensive and business strategy; it’s no longer about a strategy for invention and progress.

Instead, it’s just as much about how to keep my competitors off the marketplace, how can I build my fences, how can I keep my profits at the highest, when, really, we should be allowing progress to happen in a different way. For anyone who is a free-market person, the way the patent system works today is antithetical to a free market.

Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses lessons learned from Allergan's transfer of patents to a sovereign tribe.

Tahir Amin: Lessons Learned from Allergan's Patent Transfer

How has last year’s Supreme Court ruling in 

Well, it changes the biosimilar landscape in that now, biosimilar developers can go ahead and file declaratory judgment actions. They don’t need to participate in that long and tortuous patent dance that was required. I think it makes it a little bit easier for biosimilar developers.

Sal Patel, JD, partner at Schiff Hardin, LLP, explains how the Supreme Court's 2017 ruling in Sandoz v Amgen changed the biosimilars landscape.

Sal Patel, JD: How Sandoz v Amgen Changed the Biosimilars Landscape

Recently, a biosimilar developer settled with AbbVie to end patent litigation over Humira. Do you think we’ll see more settlements like this in the future?

Absolutely. I think just as we see in Hatch-Waxman cases, I think there will be creative settlements that will be employed to end the uncertainty and the cost of the [Biologics Price Competition and Innovation Act, BPCIA] litigation, which I anticipate is going to be much higher than what we see with Hatch-Waxman litigation.

Sal Patel, JD, partner at Schiff Hardin, LLP, explains why he expects to see more settlements between drug manufacturers in the future.

Interviews