Over the past decade, there have been significant advancements in the variety of insulins available to patients with diabetes, including the introduction of biosimilar insulins. These biosimilar insulins have recently been approved as interchangeable, offering additional options for patients at a lower cost. However, it is important for healthcare professionals, particularly pharmacists, to understand the nuances of biosimilar classifications and insulin biosimilar classifications to properly dispense these medications.
The FDA defines a biologic product, or biologic, as a large molecule derived from a natural source, such as insulin, which is produced using bacteria or yeast. Insulin, once considered a drug, is now considered a biological product. On the other hand, a biosimilar is a biologic that is highly similar to an FDA-approved reference product with no clinically meaningful differences in safety, potency, and purity. Biosimilar products are differentiated from their reference products by having 4 letters after the product’s name.
Since the passage of the Biologics Price Competition and Innovation Act in 2010, the FDA has dedicated additional resources to support the development of biosimilars. Biosimilars provide opportunities to increase competition among manufacturers and reduce patient costs. This is particularly important for individuals with diabetes who require insulin, as the price of insulin has significantly risen over the past two decades.
Currently, two biosimilar insulins have been approved as interchangeable products for insulin glargine: insulin glargine-yfgn (Semglee) and insulin glargine-aglr (Rezvoglar). Interchangeable biosimilars can be substituted without the approval of the prescriber in states where the laws allow it. These interchangeable insulins have been shown to lower the cost of basal insulins, providing more affordable options for patients.
It’s important to note that biosimilars are not automatically cheaper than their reference products. The cost of biosimilar insulins may vary depending on factors such as insurance coverage and discount programs. However, the approval of interchangeable insulin products has created an opportunity for cost savings.
At present, there are no bolus/prandial/rapid/short-acting biosimilar insulins that are FDA-approved as interchangeable with reference products like insulin aspart, insulin lispro, or insulin glulisine. However, ongoing research and clinical trials may result in the availability of biosimilar alternatives in the future.
In order to make informed decisions and provide accurate information to patients, pharmacists can utilize various resources and references to stay up-to-date on the latest information about biosimilar insulins. By staying informed, pharmacists can confidently navigate the realm of insulin biosimilars and ensure that patients with diabetes receive optimal care.
Sources:
– FDA Purple Book database of licensed biological products
– GoodRx and SingleCare discount card providers
– Various resources listed in Table 2 of the source article
