Jeff Baldetti, MBA, is director of biosimilars for Cardinal Health.

Jeff Baldetti, MBA

Six years after the first biosimilar launched in the United States, at long last we have an interchangeable biosimilar available. The first interchangeability designation was granted to Biocon Biologics and Viatris’ Semglee (insulin glargine-yfgn) this week, referencing the long-acting insulin Lantus, which may allow pharmacists to substitute the biosimilar at the counter without consulting the prescribing physician, per state laws. Although the concept of interchangeability may not seem like a groundbreaking idea, the ability to substitute Semglee at the pharmacy could enable faster uptake and broader adoption of retail biosimilars in the United States.

The introduction of the interchangeability designation could unlock lower health care costs and improve access for patients nationwide by providing competition against some of the costliest and most widely used biologic treatments available on the market: insulin products. However, the success of these products will be contingent on several factors including awareness and comfort among providers and patients, pricing strategies that create meaningful discounts for patients, payer and pharmacy benefit manager (PBM) formulary policies, and federal- and state-level regulatory policies.

Although discovered in 1923, insulin remains one of the most expensive treatment options for patients with diabetes in the United States almost 100 years later. Between 2001 and 2018 the average list price of insulin products has increased around 

. For many of the roughly 30 million Americans living with type 1 and type 2 diabetes today, these daily insulin injections are lifesaving medications. With more than 

1.5 million new cases diagnosed every year

 and the cost of diabetes-related care continuing to increase, interchangeable insulin biosimilars could be integral cost-saving tools.

Unlike the 20 other commercially available biosimilars in the United States that are primarily billed under a patient’s medical benefit and dispensed at hospitals and clinics, Semglee is the first biosimilar predominantly dispensed at retail pharmacies and billed under a patient’s pharmacy benefit. Further, it is the first biosimilar to be designated as interchangeable by the FDA. An interchangeability designation is achieved by submitting additional data to the FDA for review (eg, additional switching studies) and does not mean that a product is “clinically superior” to a non-interchangeable biosimilar. With the transition of insulins to be regulated as biologics in March 2020, the FDA released additional draft guidance specifically for insulins stating that switching studies may be unnecessary to support the demonstration of interchangeability. This draft guidance essentially created an easier path for insulin biosimilar candidates to achieve an interchangeable designation. It is important to note that interchangeability is a regulatory designation only in the US market; and because these products will be available through retail pharmacies, interchangeability presents the possibility for very different dynamics than we have seen with other currently available biosimilars.

Most patients with diabetes (87% per IQVIA database) receive their prescribed treatment through a retail or mail order pharmacy, enabling greater opportunities to interact directly with community pharmacists or pharmacy technicians. With the potential empowerment to automatically substitute biosimilars that may be significantly less costly than reference biologics, retail pharmacists could have fewer barriers to converting patients to insulin biosimilars, assuming broad PBM/payer coverage. The introduction of a new competitor in the insulin market is a big step toward enabling competition to drive costs lower and enhance access to insulins for the diabetes population. With approximately a quarter of patients 

 in the United States, biosimilars have significant potential to address insulin affordability and minimize the risk of negative outcomes associated with 

 due to medication noncompliance. Additionally, broad experience with insulin biosimilars over such a large market of patients will further strengthen comfort with the overall product class, eventually paving the way for faster adoption for future biosimilars, such as adalimumab biosimilars in 2023.

For the first time, retail pharmacists will be tasked with navigating the considerations associated with managing reference products, biosimilars, and interchangeable biosimilars.

Although the stage is set for Semglee to significantly impact the insulin market, success of Semglee and future interchangeable biosimilars will be contingent on multiple factors:

For the first time, retail pharmacists will be tasked with navigating the considerations associated with managing reference products, biosimilars, and interchangeable biosimilars. As some of the most accessible and frequently visited health care providers, retail pharmacists can now play a significant role with counseling and educating patients on biosimilar products. However, with reimbursement profiles, patient out-of-pocket costs, and payer coverage all varying by product, many retail pharmacies will also be tasked with managing the complex financial environment and operational implications that many in the physician office and health system space have experienced thus far with biosimilars. As it stands today, product list prices and payer coverage policies for insulins are anything but uniform.

Further, in the drug channel, insulin has been referenced as one of the most heavily rebated product categories on the market, where 

gaps between gross and net price can stretch to well over 50%.

 Although biosimilar list prices may be lower than for reference products, biosimilars could potentially end up in 

 formulary positions if they are unable to match the net costs that reference products can deliver through rebates. This managed care dynamic could lead to more restricted formulary access for biosimilars, minimizing the functionality of the interchangeability designation. For interchangeable biosimilars to function effectively, the drug channel may need to adapt to this new market as the existing pricing and rebate environment continues to draw scrutiny from patients and government officials alike. Although the first insulin biosimilars will likely face an uphill battle, the components for developing a highly competitive biologics market for the retail channel are beginning to take shape.

The health care industry will eagerly wait to see whether insulin biosimilars live up to the promise of providing greater access and lower costs for the millions of Americans who rely on this lifesaving treatment.

With Semglee’s interchangeability designation, the health care industry will eagerly wait to see whether insulin biosimilars live up to the promise of providing greater access and lower costs for the millions of Americans who rely on this lifesaving treatment. With a new insulin competitor now on the market, the door is open to address the continually rising costs of diabetes care in the United States.

Looking ahead, the insulin experience could serve as an important learning opportunity for the US health care industry as we prepare for more interchangeable products in the future. Building on our experiences with this first interchangeable biosimilar will help strengthen our health care infrastructure and potentially accelerate needed access to high quality, lower cost treatment options in additional therapeutic areas. With the potential for multiple interchangeable adalimumab products in addition to the 6 already FDA-approved adalimumab biosimilars, we expect this market is just the beginning of a new era for biosimilars—one the US health care system has anxiously awaited over a decade to see come to fruition.

To help pharmacists and pharmacy technicians navigate their state’s specific guidelines and support patients with biosimilar adoption, Cardinal Health partnered with regulatory advisors to develop an interactive map that details state-by-state interchangeability laws, and is available at the following link: 

www.cardinalhealth.com/biosimilars/statelaws

Articles

The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar will be a test of whether such designations can make a difference in patient access, Jeff Baldetti, MBA, of Cardinal Health explains. 

Jeff Baldetti, MBA

Opinion: How Will Semglee Interchangeable Insulin Affect Access and Affordability?