What kind of responsibility does the FDA have to assure providers and patients that biosimilars are safe and effective products?

So obviously, FDA play a clear role in educating all stakeholders around the misinformation [about biosimilars], but they also have an important role in terms of the confidence that they can instill in physicians and patients around biosimilars. These products undergo a rigorous review by FDA and patients and healthcare providers alike should be confident in their efficacy and the safety and the quality of the products. FDA could help us with that by reinforcing that confidence when new approvals are announced, for example.

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Carol Lynch, president of Sandoz US and head of North America, discusses the FDA's role in instilling confidence in biosimilars.

Carol Lynch: Instilling Confidence in Biosimilars

Do you think there is potential to increase biosimilar uptake in the United States?

I think that the promise of biosimilars is still there for the US market. I think the savings potential is enormous and the ability to expand access for patients to biologic medicines is tremendous. There are estimates out there that for every day, for example, a biosimilar etanercept is not available on [the] market that it’s actually costing millions of doctors.

We actually got approval for Erelzi in August of 2016 and yet we’re still not allowed to market this product because we’re in litigation and we can’t bring it to market until that court case has been resolved. At this rate, it looks like it will be around $3 billion of savings that have been missed, and for patients in the system and for the healthcare system as a whole, I think that’s something that we all need to take on.

Carol Lynch, president of Sandoz US and head of North America, discusses the promise of the US biosimilars market. 

Carol Lynch: Future of the US Biosimilar Market

In efforts to address drug costs, some US states have passed legislation attempting to rein in drug prices. What are some of the common features of these laws?

When we talk about the states in contrast to the Congress, states have actually done an awful lot over the last 5-10 years on drug pricing, and it’s an accelerating trend. By one count, almost all of the states had some kind of proposals that they were considering last year [2017] and a number of them have been enacted.

I actually recently did an analysis where I counted 11 different categories, and we put out a client alert about it, 11 different categories of state actions on drug pricing. Everything from, kind of transparency-type rules where, if a product’s price is increased, it has to be reviewed by the state and potentially approved, to approval of importation from non—US jurisdictions, to repeal of “gag” rules where you walk in and the pharmacy has to tell you the cash price versus the price if you use your insurance, studies of drug pricing.

Many different experiments, if you will, where the states are taking a creative approach and in a lot of cases are actually enacting things. Now, some of these efforts are not without legal challenges. Some have already been successful, Maryland had a price-gouging bill that was struck down by the first court that heard it, and there will be others like that, but I think we are going to continue to see the states being very active in this area and having an impact.

James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, discusses state laws targeting drug prices.

James Shehan, JD: State Efforts to Address Drug Costs

The US market is going to have to wait for biosimilar versions of AbbVie’s drug Humira because the AbbVie has accumulated a number of patents on the drug. In fact, our study found they have filed over at least 247 applications for Humira. Many of these will expire in 2037 and as a result of the stockpiling of patents that AbbVie has compiled, it is going to delay biosimilars in the market at least until 2023, and I think what’s important about that is that the companies that have agreed licenses with AbbVie to enter the market in 2023 will still be paying royalties, according to reports, to AbbVie. So those are going to go back to the consumer as well, even when biosimilars come to the market, and AbbVie’s chief financial officer has actually gone on record and said that they’re quite pleased with their patent and legal strategy and this is why we’re not seeing earlier entry of biosimilars in the US market.

I think it’s also worth saying the regulatory procedure under the [Biologics Price Competition and Innovation Act] in the United States is different to that in Europe, so getting a biosimilar version on the market in Europe is less onerous…and that’s also why we see a quicker uptake in the market in the European market. It’s also worth mentioning that the number of patents that AbbVie filed were considerably fewer; in fact there were 3 times as many patents in the US than there were in Europe and almost 4 times in Japan.

Tahir Amin, DipLP, cofounder and director of intellectual property of Initiative for Medicines, Access, and Knowledge (I-MAK), explains the role of patents in delays to US adalimumab biosimilar launches.

Tahir Amin: Why US Consumers Must Wait for Adalimumab Biosimilars

Who is responsible for addressing misinformation campaigns about biosimilars, and what can be done to stop them?

I think we all need to take on the task of tackling misinformation that’s out there, because I think, at best, it can lead to confusion for all stakeholders, and at worst, it can actually cause doubt about the safety and efficacy of biosimilars.

So, I think that from an FDA perspective they can definitely set out and help us with that. I think it’s on manufacturers to step up, but also the other players in the industry as well, so for example the medical societies, industry associations like [Association for Accessible Medicines] and Medicines for Europe, all play an important role in making sure that fair and balanced information is available to all stakeholders.

Carol Lynch, president of Sandoz US and head of North America, discusses which stakeholders have a role in addressing misinformation about biosimilars. 

Carol Lynch: Addressing Misinformation About Biosimilars

How would you characterize the state of biosimilar regulation today, and what have we learned from the first years of the Biologics Price Competition and Innovation Act (BPCIA)?

Biosimilar regulation, and this is something that I’ve been thinking about and active in for a long time in a previous role as head of government affairs at Novo Nordisk; we took a hand in shaping, you know, lobbying and negotiating, various pieces of the BPCIA.

It’s 2018, we have a law that’s been in effect 8 years, and I’d say only now are you finally starting to see real-world effects of the implementation. Fascinating, because you can always, as many people have, contrast it with Europe where they passed a law in the early aughts and within a year or 2 there were products on the market. And biosimilars to, I think, 7 different molecules by the time we passed our law and now they have many more. And we have a handful approved, and a very small number on the market. Patent challenges [are] holding up the others.

I think it is completely fair to say that FDA has been abominably slow in implementing the biosimilar law. The law puts significant hurdles in front of US biosimilars in order to get them to market. But that doesn’t mean that FDA had to take such a long time in rolling out guidances on some of these issues. And we’re still waiting, for example, on the guidance for interchangeability. I mean, not that much has changed scientifically in 8 years so what’s the hold up?

All that being said, there is a pipeline of products being worked on. I think you’ve seen some shakeout in the industry, you know you’ve got a little bit of a gold rush mentality early on and a lot of smaller players getting in who really don’t have the capacity, the capital, or personnel to solve the challenge—the rather difficult logistical challenge of developing a biosimilar. It’s essentially an effort that’s equivalent to bringing a new drug to market. So, you’re seeing some of those smaller companies going away, I saw Momenta recently laid off a bunch of their staff. It looks like a skeleton crew now, and they were a prominent early player, and there’s other examples like that.

You’re essentially seeing the big established industry—with a couple of newcomers like the biotech arm of Samsung playing a role&mdash;and litigation being an ongoing challenge to anyone trying to bring a product to market. See for example the Humira biosimilars that are approved and will not be launched until 2023 under various settlements with AbbVie.

James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, discusses the state of biosimilar regulation in the United States.

James Shehan, JD: The State of US Biosimilars Regulation

What are some barriers that are blocking market access to biosimilars in the United States?

Well, in order to be able to commercialize a product, first of all, you need to get regulatory approval, and I think we’re doing pretty okay there. If you look at the number of approvals in the [United States], it’s definitely catching up. Still behind Europe, but definitely catching up. Then you need to be able to launch.

If you look at the number of approvals, which today is 17, and yet only 5 of those products are actually being marketed today. So clearly, we’ve got an issue once we’ve had approvals to get to market, and I think that’s where the litigation barriers come in.

Then, once on market, if you look at the performance of the various products that have been launched, then you see quite an inconsistency.

Our own Zarzio was launched more than 3 years ago and has performed, I think, according to expectations of a biosimilar in a developed market. We have achieved leading market share by volume within 3 years of launch, overtaking the originator, so I would say that is a successful biosimilar. But we don’t necessarily see that across all of the brands that have been launched. So, I think there’s still some inconsistency there, and one of the major barriers is actually around the contracting and rebating practices we see from some of the originator companies.

So clearly, still a number of barriers to be taken down in order to have a vibrant biosimilar healthcare system in the [United States].

Carol Lynch, president of Sandoz US and head of North America, discusses the barriers blocking market access for biosimilars in the United States. 

Carol Lynch: Barriers to the US Biosimilars Market

What would have the biggest effect on drug pricing in America?

I think with the drug pricing debates there are a lot of options being pulled—policy levers. We fundamentally believe that unless we get to the route of the problem, which is the overpatenting problem, we will never solve the drug pricing problem. It will always remain in the powers of the pharmaceutical companies.

We have to restore much needed balance between the patent system and its incentives with how the market is failing at the moment for the public, because 1 in 4 Americans are having to make difficult choices between filling their prescriptions or putting food on the table, and we know that, according to statistics, drug prices are going to double by 2025.

We believe that there needs to be a significant correction in how we hand out these monopolies, because these monopolies are getting longer and they’re becoming that much more difficult to allow for competition in the market.

Tahir Amin, DipLP, cofounder and director of intellectual property of Initiative for Medicines, Access, and Knowledge (I-MAK), discusses how to address high US drug prices.

Tahir Amin: Addressing Drug Prices in the United States

A recent report from I-MAK said that AbbVie is one of the worst patent offenders in pharma. Why is that?

So as I said, as our study found, AbbVie is one of the worst offenders in pharma because of the number of patents it’s accumulated.

 called “Overpatented, Overpriced” where we looked at the top 12 selling drugs in the United States. Of all those 12 drugs, AbbVie has the highest number of patents for its drug. On average, we found of those top 12 selling drugs, 125 patent applications on average across those drugs, and we’ve seen price increases between 2012 and 2016—at least 68% pricing increase over that period on average.

So in that sense, AbbVie has been the most egregious actor when it comes to what we would call overpatenting deliberately. I think it’s important that if you look at the time scale AbbVie filed these patents, 89% were filed after the first approval in 2002, and even more outrageously, they filed 122 of those applications after the first patent expired in 2014.

That suggests to me that this is more than what we might call “inventions” going on in the Humira space, but that these were strategic patents in order to delay competition.

Tahir Amin, DipLP, cofounder and director of intellectual property of Initiative for Medicines, Access, and Knowledge (I-MAK), discusses AbbVie's patents on the innovator adalimumab, Humira.

Tahir Amin: AbbVie's Patents on Humira

Have you noticed any trends in congressional concern over drug pricing? 

When we talk about Congress, the interesting thing is that I think you could sum up Congress over the last decade or more as “all talk and no action,” which is interesting because drug pricing being such an issue in American politics and being something that where there is a reasonable amount of consensus across the parties that drug prices are too high, but Congress has been singularly unable to do much of anything about it, which also is interesting when you see that the administration actually is doing something about it and with all the irony of it being a Republican administration.

And maybe there’s going to be more action in the coming Congress that starts sitting in January [2019], but I think it’s going to be, again, more talk and less action particularly with 1 party controlling each house.

James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, discusses recent congressional interest in drug pricing.

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