Allowing the US Biosimilars Market to Flourish

Gillian Woollett, MA, DPhil: So it’s interesting that you say that, and I’m going to invite comments from everybody about who’s ultimately got the responsibility for doing this. But the corollary is true, therefore, if we go back to what was asked for our misinformation, education, appropriate promotion of these products, that if we don’t succeed, if those messages that are misleading can prevail for the next year and a half, we may not actually ever see a successful competitive biosimilars market in the United States.

I’m going to ask each of the panel: recognizing we’re at this critical juncture, that drug pricing is a very, very big issue in this country right now, that we do have the opportunity with the FDA having approved a good dozen biosimilars—even if they’re not all launched, we do have the [intellectual property, IP] patent thicket that we haven’t addressed in any detail, but we do need this commercial pull-through—who is most responsible?

How can we break this loose in this critical window, recognizing some urgency to both solve what is a priority for this country on healthcare access and affordability and see competition? What is the single thing you guys would suggest that can break this loose most immediately?

I’m not asking for new legislation. I’m not asking for anything complicated. What can we do to allow biosimilars to contribute in the United States in the manner that they do in Europe?

Carlos Sattler, MD: We are at a juncture. I think that there’s a perception that biosimilars have not been successful in the United States so far, notwithstanding the fact that we’re early in the process, if you may. There are examples, as Kashyap and I have mentioned. There are already some insights into cost savings, which is one of the goals, and reshifting the resources for good use, as you have described.

There’s also the current landscape, from a CMS and an [Health and Human Services, HHS] perspective, that is favorable. We’re seeing action at the FDA level and at the CMS level in trying to encourage biosimilar useage. But I don’t have one single answer, unfortunately. I think it’s going to take more than one.

For biosimilars to be effective, they have to be prescribed. So certainly prescriber education, as you mentioned, is very, very key. They have to be accepted by patients. And what you said, Kashyap, is very encouraging, that you believe that patients are not as concerned. We’ve seen otherwise, but I think there’s still a component of education to patients in order to have acceptance. And maybe as importantly—and you could argue more importantly—is that payers need to come onboard. They need to change their reimbursement policies. They need to change their approach to biosimilars. They need to really get onboard. If payers don’t get onboard, it really doesn’t matter.

So I think all stakeholders are important because you have to prescribe, and you have to accept to use, but you also have to be able to fairly reimburse biosimilars. If that doesn’t happen, then we’re not going to be successful.

Gillian Woollett, MA, DPhil: So, Julie, I’m going to give you the opportunity to sum up both what we started on, in terms of the whole idea of education, appropriate information being out there, but also invite you to pull in this consequence of, if this doesn’t happen, what does it mean? And if you’ve got the magic bullet, please feel free to share it.

Juliana Reed: Multiple things have to happen. We need the FDA to do more on education and to combat misinformation. As stakeholders, though, we need to use the FDA as the trusted source of information, and we have to help disseminate that information. That’s a key piece.

But the silver bullet—the most significant thing that has to happen here in the United States to create this robust, sustainable marketplace that will drive cost down—is [addressing] the anticompetitive access and coverage barriers that are out there. The payers have to engage. The payers have to support and drive uptake of biosimilars. That’s not just the commercial payers. That’s also the government. So we need to do that. That’s the silver bullet, and it needs to happen. We have 5% over a year with 2 infliximab biosimilars on the marketplace. The market share after over a year is only at 5%. So it needs to change, and it needs to change now.

Gillian Woollett, MA, DPhil: And, of course, we’ve seen the recent launches of the adalimumabs in Europe, but those same products, even when they’re already approved here, won’t be launched until 2023.

Carlos Sattler, MD: And I think that’s really key, because one aspect that you mentioned that we didn’t talk about is the patent landscape in the United States. It’s totally different from what we see in Europe in great measure. There are products that have been approved by the European Medicines Agency and by the FDA, and these same products are being used in patients. They’re making an impact in Europe, but they’re not in the United States. Just to give you an example, we obtained approval of our etanercept biosimilar in August 2016, over 2 years ago. We’re in patent litigation right now with the reference product manufacturer, so we can’t launch the product yet. We’ve estimated that for every month that we are not able to bring this biosimilar to market, that could be costing the healthcare system up to $95 million.

Juliana Reed: We did a similar study but on access for the infliximab biosimilars, and our study showed over $500 million—a half a billion dollars—of lost cost savings per year while that market share and the coverage remains the same. So we’re leaving cost savings on the table.

Gillian Woollett, MA, DPhil: So, overall, what I’m hearing is the good news, the experience with biosimilars worldwide has said they are every bit as safe and effective as their reference products. They’ve been extensively used in Europe and, we should say, various other markets around the world as well. They’re all made to the same appropriate high-quality standards, approved by the same reviewers at the FDA as any others. So there is no evidence of any reason for anybody to lack confidence in these products as alternatives to their reference.

However, we do have fundamental elements—it’s a little bit ironic being the United States and the ultimate competitive, putatively free market in the world—we do have fundamental elements in the United States that, unless they are changed, are precluding, in all likelihood, the long-term success of biosimilars in the United States. And that would be unfortunate for patients who will then lack access to these critical medicines, and I think none of us would say we want to undermine how important these medicines are. They really are life saving, life changing for patients.

So thank you very much. This has been an extremely informative discussion. And I appreciate the time you’ve spent considering the questions.

On behalf of our panel, we thank you for joining us, and we hope you found this Stakeholders Summit^Ò discussion to be useful and informative. Thank you.