Remarks by Acting Commissioner Ned Sharpless at the FDA Public Hearing on The Future of Biosimilar Insulin May 13, 2019

Speech | Mixed

• Speech by: Norman E. "Ned" Sharpless, MD ; Acting Commissioner of Food and Drugs - Food and Drug Administration

White Oak, MD

(Remarks as prepared for delivery)

Good morning.  And thank you for joining us for today’s very important Public Hearing.

The world of public health has never been as promising or exciting as it is today.   

Biomedical research has provided enormous opportunity to fashion new ways to prevent and treat a range of formerly intractable diseases.

But with these advances come new challenges.

One of the biggest challenges of modern medicine is the cost of many of these new (and in some cases not so new) treatments and devices.   The subject of today’s public hearing -- facilitating the efficient development of biosimilar and interchangeable insulin products – tackles this challenge.
Insulin is a life-saving medicine. 

The essential role of insulin for treating diabetes mellitus has been known since the time of Banting and Best, the early 1920’s.

As an internist, I can recall almost no condition more satisfying to treat than diabetic ketoacidosis. 

These patients would come in so sick, so near death, and we’d give them 10-20 units of good old regular (porcine or bovine) insulin, and these patients would, within hours, rise like Lazarus. 

And then they’d tell you they feel better, and often immediately want to go home.

If that does not make you feel like a real doctor, nothing will.

And although insulin is an old medicine, through recent advances in science and technology, it has been improved in many ways in terms of formulation, monitoring and delivery; making diabetic care much simpler for patients and their families, and reducing the risks of long-term diabetic complications. 

Earlier this year, for instance, the FDA approved the first interoperable insulin pump intended to allow patient to customize treatment through their individual diabetes management devices.

And last year we expanded the approval of an automated insulin delivery and monitoring system for use in younger pediatric patients.

FDA has approved three follow-on insulin products [Basaglar, Lusduna, Admelog] since 2015.

But against this backdrop of ongoing and hopeful medical progress is a continuing increase in the prices of insulin products. 

One study [from the Schaefer Center] documented that the average list price of four insulin categories increased on the order of 16 percent annually from 2012 to 2016.

And a report released late last year by the Congressional Research Service noted that the list price of one type of insulin had increased nearly 600 percent from 2001 to 2015.

It hardly needs to be said that these kinds of whopping and steady price increases make it increasingly difficult for many insulin-dependent patients to afford the basic medicines they need to survive.

As a physician, I find this intolerable:  no patient should have to choose between paying for their medicine and paying for their rent. 

I know this audience is well aware of the recent news reports of people who have felt the need to stockpile insulin.  Or reports of patients who couldn’t get the insulin they needed, and died as a result.

As a regulatory agency focused on science and evidence-based care, the FDA is working to support the advancement of new treatments and to build a system of public health that strengthens access to needed medical care. 

At the same time, we’re also very focused on making sure that the drugs patients need are more affordable and accessible. 

One of the best ways to achieve this is to increase market competition through the introduction and expansion of safe and effective generic drugs. 

We’ve seen great success in this area, with record levels of generic drug approvals in recent years. 

Generic drugs account for more than 90 percent of prescriptions in the US, and the generic drug supply in American is highly regulated and very safe.   

Unfortunately, however, not all pharmaceutical products are amenable to competition through the generic pathway.  

That has been the case for insulin products, because insulin is regulated as a biologic, meaning a complex molecule generally manufactured in living cells. 

Biologics increasingly are a mainstay of modern medicine, playing a critical role in the treatment of serious illnesses, and often presenting the only effective treatment option for some patients. 

In fact, biologics today account for about a third of new therapies approved by the FDA.

Unfortunately, because of their complexity, it’s been difficult to increase competition in the market for biological products. 

One can think of it this way:  biosimilars are to biologics as generics are to small molecule drugs.

Until recently, there was no pathway for FDA to approve products that are biosimilar to, or interchangeable with, brand name products, as there is for small molecule drugs. 

Thanks to several important legislative, regulatory, and policy changes, however, the FDA expects that this about to change. And the opportunity for companies to develop new, less expensive biosimilar and interchangeable insulins will be possible. 

In 2010, Congress passed the Biologics Price Competition and Innovation Act, which created a pathway for approval of biosimilar and interchangeable products. 

What this means is that biologics are now open to competition, providing more treatment options to patients at potentially lower prices. 

We’ve taken important new steps to implement this pathway and promote this type of competition, pursuant to Congress’s direction. 

Our Biosimilars Action Plan, released last year, is designed to improve the efficiency of the biosimilar and interchangeable product development and approval process by providing increased scientific and regulatory clarity for the biosimilar development community. 

And we’re already seeing results.  The FDA has approved 19 biosimilar products, with many more biosimilar development programs underway.

And last week, the FDA issued a final guidance on interchangeability of biosimilar products, describing the regulatory path whereby biosimilars can be substituted, without the involvement of the prescriber, for branded biologics.

This is important, and is a key step toward controlling the prices of biologic drugs in general.

But today, we are here to talk specifically about insulin.

At Congress’ direction, we are transitioning, effective next March, certain applications for biological products currently approved under the Food Drug and Cosmetic (or FD&C) Act to be biologics under the Public Health Service (or PHS) Act. 

That’s a mouthful, I know.  But make no mistake.  It’s an important and meaningful change.  And it offers promise for insulin products.

This is a little complex, but let me try to explain. While insulin products are proteins (or biologics), they historically have been regulated under the FD & C, which governs the approval of drugs and generics, rather than the PHS, which governs the approval of most biologics.

By moving insulin and other applicable products to be under the PHS , Congress has promoted a pathway for follow-on insulin products to become available.  So this means that insulin and insulin analogs will now be open to biosimilar competition.

Which in turn can lead to development of more affordable biosimilar insulin products, including products that are interchangeable with branded insulins, without any compromise in safety and effectiveness. 

We’re hopeful that the approval of interchangeable products will translate into increased competition -- meaning lower costs -- and increased access for patients. 

According to the timetable in the statute, insulins and other biological products historically regulated under the FD&C will not transition to the PHS until March 2020. 

And while this is slower than many of us would like to see, it is clear that there is already a great deal of interest among potential sponsors.

We’re not where we want or need to be yet.  But we’re getting closer.  And we’ve taken some important steps. 

Today’s Public Hearing is another key step – the opportunity to hear from all of you -- stakeholders directly affected by the price of insulin and who would benefit by the impact of additional competition from biosimilar and interchangeable products. 

We want to hear from you about what factors we should consider in evaluating information submitted by applicants for new biosimilar products.

What scientific standards should we use for evaluating, within the bounds set by the statutory requirements, whether an insulin product is biosimilar or interchangeable to a reference product? 

Do certain products, like insulin pumps for continuous subcutaneous infusion raise unique scientific considerations that we should be considering when evaluating biosimilar or interchangeable insulin products?

And we want to know what aspects of the patient experience with insulin products should FDA consider when making this evaluation? 

Finally, what kinds of information and resources do we need to develop to foster effective communications and promote awareness among patients, clinicians, pharmacists, and other stakeholders about biosimilar and interchangeable insulin products?

Your voices are what will help spur and shape the development of our policy in this area to meet public health needs.

Working together, we can advance the development of biosimilar insulin products that are more affordable, effective, and accessible.

Thank you, and I look forward to your comments and a great meeting.