FDA approves first interchangeable biosimilar insulin

Abstract

In July 2021, FDA approved the first interchangeable biosimilar insulin product (Semglee–Viatris/Biocon Biologics, insulin glargine-yfgn), which can be substituted for its reference product (Lantus–Sanofi Aventis, insulin glargine) at the pharmacy level, depending on state pharmacy laws. Although FDA first approved Semglee in June 2020 to improve glycemic control in pediatric patients with type 1 diabetes and adults with type 1 or type 2 diabetes, this approval marks the first interchangeable biosimilar designation for insulin from the agency. “The approval of an interchangeable insulin glargine may offer cost savings to select patients, as biosimilars have, on average, launched with lower initial prices compared with their branded counterparts,” said Daphne Smith Marsh, PharmD, BC-ADM, CDCES, a clinical pharmacist in ambulatory pharmacy services at Mile Square Health Center in Chicago. However, she added there are several other considerations that health care practitioners must keep in mind. “Pharmacists should understand that Semglee can be substituted for Lantus without intervention of the prescriber, but currently cannot be interchanged with Basaglar–Lilly, another insulin glargine product on the market,” she said. “If patients previously receiving Lantus are given Semglee at the pharmacy, patient education is essential to avoid duplication of therapy, as some patients may not understand that they are the same type of medications and may continue to use both products once they get home.” Biologics are large, complex molecules that usually contain a mix of many slight variations of a protein that cannot be copied exactly. FDA does not approve a biosimilar product as interchangeable unless the company specifically seeks an interchangeable designation. The application includes additional data and information about the impact of switching or alternating between the biosimilar product and the reference product. According to FDA, a manufacturer of a proposed interchangeable product must show that the product is biosimilar to a reference product and that it can be expected to produce the same clinical result as the reference product in any given patient. Additionally, the manufacturer must also demonstrate that, for a product administered to a patient more than once, there is no additional risk or reduced efficacy if a patient switches back and forth between an interchangeable product and a reference product, compared to using the reference product without switching. FDA's “Purple Book” contains more information on biologics, biosimilars, and interchangeability, under the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” Also, APhA has created an FAQ document—available at pharmacist.com/Advocacy/Issues/Biosimilars—to help our members and their patients navigate the rapidly evolving biologic and biosimilar landscape. Pharmacists should consult their state pharmacy association to understand their specific state law for pharmacy-level substitution, since it can vary from one state to the other. For example, in most states, patients will need to be told they are getting an interchangeable biosimilar and pharmacists will not be allowed to make the switch if the prescribing physician has expressly indicated they are prescribing the reference product (e.g., Dispense as Written [DAW], Brand Medically Necessary). Smith Marsh said that patients receiving Semglee should understand that this is not a generic form of Lantus and that it works the same way as that medication. Patients should have a general understanding of what a biosimilar is and how these products are similar to their reference product. Patients should also be educated on all basic insulin counseling pearls, such as appropriate dosing, proper use of the multidose vials or pens, the correct way to discard any unused portions after 28 days, and potential adverse events (e.g., signs/symptoms of hypoglycemia, injection site reactions, edema, weight gain, etc.). Smith Marsh recommended that patients be encouraged to inform their prescribers of the switch.