Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access

FDA Statement

• For Immediate Release: April 02, 2019

Access to affordable insulin can be a matter of life and death for Americans with diabetes. Insulin is a critical hormone that regulates sugar metabolism. The body’s inability to produce sufficient levels of natural insulin can lead to diabetes – both inherited Type 1 and Type 2, typically called adult onset. Diabetes affects nearly 30 million Americans and can lead to serious and life-threatening complications, including heart disease, organ failure and blindness.

Diabetes takes a tremendous toll on Americans, both physically and economically. It remains the seventh leading cause of death in the U.S. and accounts for $330 billion in annual health care spending. While some patients with Type 2 diabetes can control their diabetes through diet, exercise and oral medications, more than seven million diabetics require daily insulin injections to maintain glycemic control and reduce the risk of health complications. But access to this critical drug can be increasingly difficult for these Americans. Insulin list prices regularly increase by double digits annually. These increases have raised serious concerns about the ability for many patients to access the insulin needed to survive.

As a society, we must ensure that everyone who needs insulin has access.

Driving down drug prices requires a comprehensive approach. But one impactful route is through competition. This is particularly true following the introductions of generics, especially when there are three or more generic competitors – which has been shown to bring down prices more sharply than with only one or two generic competitors. A robust pathway for generic competition is critical to expanding drug access and promoting public health. The FDA has worked hard to encourage generic entry after patents and other exclusivities have lapsed. Ours is one of the most competitive generic markets in the world.

But there is more to do and we’re committed to further expanding access to these high-quality, affordable products. Not all parts of the pharmaceutical market have been equally open to competition from more affordable products. This is especially true for biologic medicines, which are typically complex molecules produced by living cells, and are increasingly the backbone of modern therapy.

Until recently, biologics lacked effective competition because there was no abbreviated pathway for bringing follow-on versions of biologics to market under the Public Health Service Act (PHS Act), similar to the generic pathway we have for small molecule drugs under created under the 1984 Hatch Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). In 2010, Congress, through the Biologics Price Competition and Innovation Act (BPCI Act), gave the FDA the authority to implement a pathway for approval of biosimilar and interchangeable products, to open biologics to competition, ultimately providing more treatment options, increasing access to lifesaving medications and potentially lowering health care costs.

We’ve set out in recent months to advance new policies to promote more competition when it comes to biosimilar products and to advance our overall framework that improves the efficiency of the biosimilar and interchangeable product development and approval process. This includes new steps to implement Congress’s direction that we transition certain biological products currently approved as drugs under the FD&C Act to be licensed as biologics under the PHS Act, making them subject to biosimilar competition.

Transitioning biological products currently regulated as drugs to being regulated as biologics will enable – for the first time – products that are biosimilar to, or interchangeable with, these products to come to market. The FDA can play an important role in encouraging competition by implementing a robust pathway for biosimilar competition. We’re taking new steps to advance this framework.

This transition is particularly important for insulin.

Although they are biologics, insulin products have historically been regulated under the FD&C Act rather than the PHS Act, which governs the FDA approval of most biologics. Biologics are typically isolated from a variety of natural sources – human, animal or microorganism – and may be produced by biotechnology methods and other cutting-edge technologies. Due in part to the complexities of these products, it has been hard to bring a substitutable generic insulin to the market under the FD&C Act.

The transition of insulin from the drug to the biologics pathway will open up these products to biosimilar competition. We’re already seeing robust activity among sponsors seeking to bring forward biosimilar copies of insulin. The framework for demonstrating that these insulin products are interchangeable should also be efficient and achievable. Bringing forward generic copies of insulin under the old drug pathway was challenging. Generally, it was difficult to prove sameness for a biological product under the Hatch-Waxman pathway for traditional generic drugs. We believe the biosimilar pathway will enable a more robust route for developing lower cost copies of insulin, including products that are fully interchangeable with branded insulins.

Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and lower costs for patients. The FDA anticipates that biosimilar and interchangeable insulin products will bring the competition that’s needed to help bring affordable treatment options to patients.

As we transition biologics to this pathway, we recognize there are unique challenges associated with bringing biosimilar and interchangeable insulin to market. We’re working now – in advance of the 2020 transition – to build a solid regulatory foundation for the review and approval of biosimilar and interchangeable insulin products. That’s why today we’re announcing a public hearing to discuss access to affordable insulin products, as well as the scientific and regulatory issues related to the development and evaluation of biosimilar and interchangeable insulin products.

At the public hearing, we want to hear from stakeholders about what factors the agency should consider when evaluating data and other information submitted by an applicant, including from analytical and clinical studies, to determine whether an insulin product is biosimilar or interchangeable to a reference product. We also want stakeholder feedback on whether certain insulin products, for example, those that use insulin pumps for continuous subcutaneous infusion among the approved uses or those approved with over-the-counter marketing status, raise unique scientific considerations that we should be considering when evaluating biosimilar or interchangeable insulin products. Importantly, we’ll also be seeking input directly from patients about their experience with insulin products and this input will inform the FDA’s approach to implementing the regulatory pathway for biosimilar and interchangeable insulin products.

We understand the urgent need to address the high prices and lack of competition in the insulin market. Ultimately the input we receive at the public hearing will help to inform steps the FDA can take to advance access to insulin products, including biosimilar and interchangeable insulin products. We’re also interested in how the agency can encourage the development of biosimilar and interchangeable insulin products while achieving the balance between competition and innovation intended by Congress in the BPCI Act.

The work of the agency leading up to the 2020 transition is vitally important. In December 2018, we took a suite of actions designed to advance the agency’s biosimilar framework. We also recently updated our policy on the naming of biologics, clarifying that all new biologics, biosimilars and interchangeable products will receive a suffix to their core name to aid in effective pharmacovigilance.

The new policy also clarified that transition biological products, such as insulin products approved under the FD&C Act, will not have their names changed. Newly approved biological products, including biosimilar products, will continue to receive a suffix in their proper name. Generally, the only biologics without a suffix will be older products that were approved before the suffix policy was implemented.

The FDA’s work to advance the pathway for biosimilar and interchangeable insulin products is also complemented by other steps the agency is taking as part of its Biosimilars Action Plan (BAP). We are committed to ongoing enhancements to the review of biosimilar applications and to providing greater regulatory and scientific clarity for biosimilar applicants and other stakeholders. The FDA will be announcing additional progress in the coming months, including the issuance of guidance on interchangeablity, as outlined in the BAP. We’ll also continue to address potential barriers to biosimilar competition as they emerge, including new steps in partnership with colleagues at the Federal Trade Commission.

While the regulatory transition of insulin products nears, we’re cognizant of the fact that it won’t be soon enough for the millions of Americans who struggle to pay for their insulin today. Helping to ensure patients have access to the critical drugs is a responsibility shared by all stakeholders, including manufacturers and health plans. We all need to do our part. A drug that’s nearly a century old should not have a list price that increases between 15-17% annually. American patients who rely on insulin to live deserve to have high-quality, affordable options. The FDA is dedicated to facilitating access to insulin. We hope our industry partners will join us in doing all we can to help people who need access to the live saving medicines, now.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.