In recent years, there have been significant advancements in the availability of insulins, including the emergence of biosimilar insulins. These biosimilar insulins provide more options for patients with diabetes at a lower cost. However, it’s crucial for pharmacists to understand the classifications and nuances of biosimilar insulins for proper dispensing.
Insulin, originally classified as a drug, is now considered a biological product or biologic. It is a large molecule derived from natural sources such as bacteria or yeast. On the other hand, a biosimilar is a biologic that closely resembles an existing FDA-approved biologic agent, known as the reference product. Biosimilar products must have no significant differences in terms of safety, purity, and potency compared to the reference product.
In 2010, the Biologics Price Competition and Innovation Act was passed, leading to increased development of biosimilars. The first biosimilar insulin, filgrastim-sndz, was approved in 2015. The development of biosimilars has become an essential strategy to enhance competition among manufacturers and reduce patient costs. This is particularly important for individuals with diabetes as insulin prices have skyrocketed over the past two decades.
Currently, there are two interchangeable biosimilar insulins on the market. Insulin glargine-yfgn and insulin glargine-aglr have been approved as interchangeable products for insulin glargine. By being interchangeable, these biosimilar insulins can be substituted for the reference product without needing specific approval from the prescriber in states where it is allowed.
One of the significant advantages of interchangeable biosimilars is the potential cost savings. On average, the prices for interchangeable biosimilars are significantly lower than the reference product. For example, the cost of Lantus pen injectors was $345 to $352, while the cost of insulin glargine-aglr and unbranded insulin glargine-yfgn was around $98. The average wholesale prices for the interchangeable biosimilars were also significantly lower.
It’s important to note that not all biosimilar insulins are interchangeable. To be classified as an interchangeable biosimilar, the manufacturer must submit additional data to the FDA, proving the safety and efficacy of switching from the reference product to the biosimilar. Pharmacists should consult the FDA’s Purple Book database to determine whether a biologic product is interchangeable.
As of now, there are no interchangeable biosimilar bolus/prandial/rapid/short-acting insulins on the market. However, there are ongoing clinical trials for biosimilar versions of insulin aspart and insulin aspart premix 70/30. It is likely that more biosimilar insulins will become available in the future.
In conclusion, biosimilar insulins offer a more affordable alternative for patients with diabetes. Pharmacists play a crucial role in navigating the realm of insulin biosimilars and ensuring patients receive optimal diabetes care. By staying informed and utilizing available resources, pharmacists can provide accurate information and make informed decisions when it comes to insulin dispensing.
Sources:
– FDA Purple Book database
– FDA: What You Need to Know About Biosimilar and Interchangeable Insulins
– GoodRx and SingleCare discount card websites
