Five Key Things Pharmacists Need to Know As Insulin Biosimilars Come to Market

The FDA approved the first interchangeable biosimilar in the United States on July 28 for Viatris’ Semglee (insulin glargine-yfgn), achieving a much-anticipated milestone since the development of the Biologics Price Competition and Innovation Act. The approval could disrupt one of the oldest, costliest and most commonly used biologic products on the market: insulin.

The availability of insulin biosimilars can bring high-quality, lower cost treatment options for pharmacists, physicians, payers, and patients alike. As the first interchangeable biosimilar that is also the first to be primarily dispensed at retail pharmacies, retail pharmacists may now be in a position to make decisions on whether to fill prescriptions with the reference products or the biosimilar products.

The interest in insulin biosimilars is expected to be strong. Today, roughly 8 million Americans use daily insulin injections to treat type 1 or type 2 diabetes—yet many face challenges affording their medication, with as up to 25% resorting to insulin rationing.

Currently, 3 manufacturers account for over 95% of the global insulin supply, and between 2001 and 2018, the average list price of insulin products has increased approximately 11% annually. The approval of interchangeable insulin biosimilars will enable increased market competition, which may help to lower health care costs and improve outcomes for patients with diabetes.

With their introduction, retail pharmacists will be positioned to support biosimilar adoption and serve as educational resources for their patients and communities.

Below are 5 key things to know as insulin biosimilars come to market:

1. What is a biosimilar?

A biosimilar is an FDA-approved biologic product that is highly similar to, and just as safe and effective as, an existing FDA-approved biologic product, also known as the reference product.Like generics, biosimilars are expected to produce the same clinical result as a reference product in any given patient, at lower costs. However, unlike small molecule generics that are manufactured from chemical compounds, biologics are large, complex molecules manufactured from living cells and therefore cannot be identically replicated—hence the term “biosimilar.”

Biosimilars are approved through an abbreviated pathway under section 351(K) of the Public Health Service Act for biological products shown to be biosimilar or interchangeable with an FDA-licensed reference product. The biosimilar approval pathway was developed with the promise of lowering costs and increasing access to critical treatments for chronic and severe conditions.

Since the first biosimilar was approved in the United States in 2015, 30 biosimilars have now been approved by the FDA. However, only 21 of them are available on the market due to patent litigation settlements, and all but insulin are primarily medical benefit products, meaning they are administered by a provider in a hospital or clinic setting. The insulin biosimilar is the first to be available to a wider patient population through retail pharmacies and primarily billed under the pharmacy benefit.

2. What is interchangeable designation?

Defining interchangeability may be easiest by starting with what it is not. It is not a clinical designation, nor an indication that the product is clinically superior to a non-interchangeable biosimilar. Rather, interchangeability is a regulatory designation, unique to the United States, that is achieved primarily through the submission of additional data to the FDA.

Interchangeability means that the biosimilar is expected to produce the same clinical result as the reference product in any given patient, which can be demonstrated through switching studies in which patients are switched between the reference product and the biosimilar multiple times.

With the FDA’s decision to transition insulin products to be regulated as biologics in March 2020, they released additional draft guidance stating that switching studies may be unnecessary to demonstrate interchangeability for insulin products. This step essentially cleared the path for insulin biosimilars to earn the interchangeable designation more easily, which led to Semglee (insulin glargine-yfgn) becoming the first in the United States to receive it.

More important than the regulatory processes are the practical implications of the designation for pharmacists. Interchangeability may allow pharmacists to automatically substitute an interchangeable biosimilar in place of a reference product without the need to consult the prescribing physician, per their individual state laws (e.g., pharmacist-level substitution).

3. Why state regulations matter

Because pharmacy laws and regulations are managed at the state level, biosimilar interchangeability policies may vary from state to state. Currently, all 50 states and the District of Columbia have laws pertaining to interchangeability, including requirements related to provider notification/permission, patient communication, and documentation practices. In addition, some states require that interchangeable products can only be swapped if the cost is lower, which adds a need for a deeper understanding of the managed care landscape and impact on patient out-of-pocket costs.

Experts agree that although states have implemented regulations before the first interchangeable biosimilar comes to market, they may need to be updated to adapt to market dynamics later on. To help navigate specific state rules regarding interchangeability, a map of current state regulations for interchangeable biosimilars is available here: Biosimilar Interchangeability State Laws.

4. The financial aspects are complex

It’s no secret that cost and reimbursement will be primary drivers for the adoption of insulin biosimilars in the United States. As the country with the highest drug costs in the world, lawmakers continue to push for the use of biosimilars and other low-cost alternatives to drive down drug prices through increased competition.

Although insulin biosimilars are expected to be priced below branded insulins, the market will be highly competitive. Insulins are among the most heavily rebated products on the market today, meaning the gap between gross and net prices is more than 50% in some cases.

Whereas gross prices are publicly available, net prices are difficult to access and can vary dramatically by pharmacy benefit manager (PBM) and payer organization. These complex dynamics may create challenges for biosimilars seeking to gain widespread formulary access.

To add to the complexity, some insulin manufacturers have introduced authorized generics, which are lower-priced versions of their branded insulins. This created an environment in which providers must navigate brand, authorized generics, and potentially interchangeable biosimilars options for insulins.

To support patients in this complex landscape, it will be important for pharmacists to understand various managed care decisions, including PBM/payer formularies and policies that ultimately dictate reimbursement and patient costs. In addition, pharmacists may play a role in identifying patients who pay cash, or are exposed to list the price for insulin products and help guide them toward alternative lower-cost treatment options.

5. Patient education will be key

As the first biosimilars primarily dispensed at retail pharmacies, the insulin biosimilar is also the first for which patient preference could play a significant role in driving adoption. Research shows that awareness and understanding of biosimilars is currently low among patients, as well as among some health care providers.

As some of the most trusted and frequently visited health care providers, pharmacists will play an essential role in educating patients about biosimilars, ensuring clinical confidence in the products and driving treatment adherence. Pharmacists can take steps to proactively educate themselves by exploring available resources provided through the FDA's Biosimilar Website, The AAM’s Biosimilars Council, and partners like Cardinal Health.

Pharmacists can also reference the “Purple Book,” which is the official database for all FDA-licensed biological products including reference biologics, biosimilars, and interchangeable biosimilars.

As insulin biosimilars make their way to market, pharmacists will be uniquely positioned to counsel patients on high-quality, lower cost treatment options, and to serve as trusted resources for providers and payers. With such high demand for affordable diabetes care in the United States, pharmacists will now have additional opportunities to do what they do best: provide patient-centered care and optimize treatment outcomes.

About the Author

Sonia T. Oskouei, PharmD, BCMAS, DPLA, Vice President of Biosimilars at Cardinal Health.