For patients with insulin-dependent diabetes, living without insulin is not an option. Quite literally, it is a life-saving medication. Unfortunately, retail prices for insulin have skyrocketed in the last decade, and new developments have remained stagnant. The good news is that a new category of insulin medication will provide new options for people with diabetes and hopefully help lower the cost of insulin.

The Growing Cost of Insulin

Of the 30 million Americans with diabetes, about 7 million of them require insulin every day. A 2022 study by Yale researchers found that 14% of people who use insulin say that the price of their medication causes significant financial hardship. Described as “catastrophic,” the spending on their insulin contributes to an extreme financial burden on their household. For these people, 40% of their income after paying for food and housing went toward the purchase of insulin.

Insulin prices have drastically increased in the past 10 to 20 years. For example, Eli Lilly’s Humalog brand of fast-acting insulin was $21 in 1996. In 2022, the price for the same vial cost ten times the 1996 price. The 2022 Inflation Reduction Act aims to address the high cost of insulin by capping the cost of insulin to $35 a month for Medicare beneficiaries. However,  non-Medicare insulin users are still subject to high prices.

The lack of competition in the insulin product market might be a reason for the high insulin prices. With the introduction of biosimilar insulin, people who use insulin may benefit from the price reduction that comes with competition.

What is biosimilar insulin?

Before defining what biosimilar insulin is, it helps to understand a few general terms used to describe the different types of insulin medication on the market.

  • Drugs: Drugs are created through a chemical process. These are small molecules to assist in addressing diabetes. Examples: Januvia, Metformin.
  • Biologic Medication: Biologic medications are made from living cells or tissue. These medications are complex molecules that help manage diabetes. Vaccines and gene therapies are considered biological medications. Examples: Insulin, Trulicity, Victoza.
  • Biosimilar Medication: Biosimilar medications are like generic drugs. These medications are highly similar and don’t differ clinically from the original biologic medicines it is patterned against.
  • Interchangeable Biologic: An interchangeable biologic is a biosimilar medication that can be used as an immediate alternative to the original medication at the pharmacy.

Understanding these basic terms reduces confusion amongst people who use insulin when discussing insulin medications with healthcare professionals. Insulin is a life-sustaining product that’s regulated by the U.S. Food and Drug Administration (FDA), and these terms help to differentiate between the various insulin medications.

What is insulin?

Insulin is a hormone made by the pancreas in most animals – including humans. However, categorizing insulin as a biologic or drug isn’t cut and dry. Although insulin meets the definition of a biologic medication because it’s made from living cells, the FDA treats insulin as a drug.

Under the FDA, drugs and biologic medications undergo different processes for approval. To ensure medication is safe and effective, the FDA categorizes its drugs and handles approvals through other avenues. Historically, however, insulin has been used longer than the FDA’s approval process for biologics. Therefore, the FDA has always regulated insulin as a drug because the approval process for biological medications was not yet developed.

FDA’s Biosimilar Medication Approval Process

In 2010, the FDA created a new approval system for generic biologics.  Called “biosimilars” or “interchangeable biologics,” the design for approval was like the one used for generic drugs.

First, the pharmaceutical company must verify their product is “highly similar” to the original biological product. The biosimilar medication must have the same level of potency, purity, and safety as the original.

Next, to be used as an “interchangeable biologic” at the pharmacy counter, the pharmaceutical company must prove the same clinical results for the biosimilar medication as the original. This step ensures that consumers can expect the same health outcomes from biosimilar medication as they would from the original medicines.

Like generic drugs, companies could manufacture biosimilar medications as long as there were no active patents on the original.

The Path to Biosimilar Insulin

For many decades, however, interchangeable biosimilar insulin was not an option for consumers. Because the development of insulin occurred prior to the biosimilar medication approval pathway, insulin was approved as a drug — not a biologic medication.

Therefore, pharmaceutical companies couldn’t introduce biosimilar or interchangeable biologics. Instead, the companies could create “generic” versions of their insulin or use the drug pathway for approval—neither of these options allowed for biosimilar insulin that could be interchangeable at the pharmacy counter.

The companies could sell generic versions of their own medication, or they could sell versions of another company’s insulin. When selling other versions, a separate prescription was required for the medication.

Good News About the Availability of Biosimilar Insulin

On March 23, 2020, the FDA moved insulin to the biologic regulatory pathway. All insulin on the market are now labeled as biologic by the FDA. In essence, this change allowed for biosimilar and interchangeable insulin. Semglee, for example, is a biosimilar insulin that works the same as long-acting Lantus but with a less costly price point.

Is biosimilar insulin different from a generic medication?

The term generic typically refers to medication that’s exactly the same as another FDA-approved, brand-name medication. Once the patent for a medication expires, other pharmaceutical companies may manufacture the drug — thus, a generic drug.

Most generic drugs are commonly referred to as small-molecule drugs and are the same as the brand name medication.

As stated earlier, generic insulin are made by the same manufacturer as the original drug. The only real difference is that the drug is not sold by its brand name. Because the generic insulin is still made and sold by the same company as the brand name, people don’t experience the same cost benefits that would typically come with other generic medications. There’s less incentive for the company to make their own generic insulin be cost-efficient for the consumer.

On the other hand, biosimilar insulin is not the same medication but affects the body the same way other similar medications do. And other companies besides the maker of the original brand name insulin can develop a biosimilar insulin.

What biosimilar is insulin available now?

In July of 2021, the FDA approved the first biosimilar insulin — Semglee. Like the long-acting insulin analog Lantus (insulin glargine), Semglee is also interchangeable at the pharmacy. Users of Lantus May now obtain Semglee instead, with the same biological effects. Another biosimilar insulin called Rezvoglar was approved by the FDA in December 2021, as another biosimilar insulin to Lantus.

Future options are on the horizon for insulin users. Lannett Company submitted an application with the FDA in 2021 for a clinical trial of potentially biosimilar insulin similar to Lantus. The potential launch of this new medication is projected for 2024, in the hopes that a Biological Licensing Application is approved for 2023.

Are biosimilar insulin products safe?

The concern regarding the safety of any new medication is understandable, which is why the FDA requires rigorous testing and manufacturing  requirements for any new products. Studies conducted using biosimilar insulin have shown the products No not only be safe, but also clinically effective in managing diabetes. These products deliver the same biological effects, immunogenicity, and safety as the original insulin medications.

What does this mean for people who use insulin?

The rise in the price of insulin has both the medical community and patients with diabetes concerned. High costs of insulin may lead some people to compromise on their medications, leading to poor health outcomes. Biosimilar insulin products may help drive down the price of insulin by creating more competition in the insulin market by offering individuals more insulin options.

In the U.S., most biosimilar insulin cost 10 to 35 percent less than the original insulin. Semglee, for example, was launched at more than half of Lantus’ market price. A significant drop in insulin prices overall, however, may take time as more biosimilar products come to market.

Biosimilar insulin also expands the number of companies interested in manufacturing insulin, which may also improve competition and drive down costs without compromising safety.

What’s in the future?

As more companies push to participate in the development and manufacturing of insulin, people with diabetes will find more options for treatment. Companies will have more of an incentive to research new treatments and manufacture biosimilar medication.

People with diabetes may see the launch of many new biosimilar medications in the forthcoming years. To date, long-acting insulin has been the focus of biosimilar insulin development. However, biosimilars to rapid-acting insulin like Novolog and Humalog are currently in the works. The expansion of insulin options not only means better competition, but people with diabetes will also have more tools to manage their health without catastrophic financial impact to their budget.