Long-Acting Insulin Biosimilars & Unbranded Biologics for the treatment of diabetes types 1 and 2

Within the treatment of diabetes, insulin is considered a standard of care and can be used to treat both type 1 and type 2. There are multiple types of insulins, one of which is glargine, a long-acting basal insulin. As of May 2022, there are five FDA-approved glargine products currently available on the market (Lantus, Semglee-yfgn, insulin glargine-yfgn, and Basaglar).

What is Semglee-yfgn

Semglee-yfgn is a biosimilar insulin glargine product and was originally approved in 2020.  However, it wasn’t until July 2021 that Semglee-yfgn received FDA approval to be interchangeable with Lantus. The interchangeable designation means Semglee-yfgn can be substituted by pharmacists for prescriptions written for Lantus. Semglee-yfgn was commercially launched in November 2021 and is now available in both a pen and a vial.  Its FDA-labeled indication matches that of Lantus and is used for glycemic control in adults and pediatric patients with Type 1 diabetes and in adults with Type 2 diabetes.

Other unbranded insulin glargine products

At the same time Semglee-yfgn was coming to market, an unbranded biologic version known simply as insulin glargine-yfgn was also launched. Unbranded biologics can be thought of in the same way as authorized generics. Where unbranded insulin glargine-yfgn is the same product as Semglee-yfgn, just packaged and marketed without a brand name.  Unbranded insulin glargine-yfgn has the same interchangeable designation with both Lantus and Semglee-yfgn.

Six months later, in May 2022, Sanofi also launched their unbranded biologic version of Lantus, insulin glargine. This unbranded biologic is the same product as Lantus and is interchangeable with Lantus, Semglee-yfgn, and insulin glargine-yfgn.

Interchangeability & Substitution at the Pharmacy

When it comes to substitution at the pharmacy, it is important to note that the two unbranded biologic products (insulin glargine, insulin glargine-yfgn) are not listed in FDA’s Purple Book. However, they are identical to their branded reference products and therefore interchangeable. Semglee-yfgn, on the other hand, is listed interchangeable in the Purple Book with Lantus as the reference product.

What does the industry say?

More than 34 million people in the US have been diagnosed with diabetes and insulin prices have continued to soar in recent years. Efforts are currently being made from within and outside the healthcare industry to make these treatments more affordable. For example, Federal and state governments are working on and/or passing legislation to cap out-of-pocket costs for insulin. 

The introduction of biosimilars and unbranded biologics has the potential to play an important role in lowering insulin costs. However, for the benefit to be seen, these products need to be priced competitively in the market.

In conclusion, Abarca believes that biosimilars and unbranded products are critical pieces in the future of affordable diabetes healthcare. Like with all medications, the manufacturers, PBMs, and health plans have a responsibility to make sure patients have access to cost-effective treatments and Abarca intends to fulfill that responsibility. 

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*This blog post was written by Brock Bizzell, PharmC., Clinical Strategy Pharmacist at Abarca Health.

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