FDA Approves Insulin Glargine as Country’s First Interchangeable Biosimilar

The FDA late Thursday approved the country’s first interchangeable biosimilar, insulin glargine.

An interchangeable designation means that the product, marketed as Semglee, can be substituted for the reference product, Lantus, automatically by pharmacists without permission from a clinician, similar to generic drugs.

The insulin market is dominated by a handful of brands and characterized by high prices, and has been the subject of various Congressional hearings and reports about the high cost of treating diabetes.

The approval “furthers FDA's longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” Acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Insulin glargine is a long-acting human insulin analog to enhance glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. Semglee is used subcutaneously once daily and is distributed in 10 mL vials and 3 mL prefilled pens.

In early 2020, insulins were added to the biologics that are approved under the Biologics Price Competition and Innovation Act approval pathway. There is much debate over whether their approval as biosimilars will help to bring more competition to the insulin market. Lantus was Sanofi's second best-selling pharmaceutical product in 2020 and generated $2.7 billion in worldwide revenue.

According to The Associated Press, Semglee injector pens, which went on sale last year but without the interchangeability designation, cost about $150 to $190 without insurance for a typical month’s supply, compared to $340 to $520 for the same supply of Lantus.

In tandem with the announcement, the FDA released fact sheets for health care providers, and these include a fact sheet about interchangable products. It has also created a Consumer Update about interchangeables for patients and caregivers.

Although they got FDA approval for Semglee in mid-2020, the manufacturer, Biocon Biologics, and its distribution partner, Viatris (formerly Mylan), have sought biosimilar and interchangeable status for this product separately because they felt it would improve the product's marketability.

According to the FDA, interchangeables carry the following criteria:

• The interchangeable is biosimilar to the reference product.
• They produce the same clinical result as the reference product in any given patient.
• There is no greater safety or diminished efficacy risk from switching between the interchangeable biosimilar and the reference product.

Because it is the first interchangeable insulin biosimilar to Lantus, the FDA approval gives Semglee 12 months of product exclusivity before the next interchangeable biosimilar to Lantus can be approved, according to Biocon Biologics.

All states have enacted laws in anticipation of interchangeable biosimilars, describing conditions under which pharmacists can substitute these agents. Predominantly, patients must be told they're getting a biosimilar substitute for the reference product and some type of registry must be created so physicians can find out that biosimilars have been dispensed. In addition, pharmacists generally will not be allowed to dispense interchangeable biosimilars if the prescribing physicians have expressly indicated on prescription forms that the originator brand is to be used.

The interchangeable designation is not meant to suggest that interchangeables are superior to biosimilars, but in order to obtain the designation, biosimilar developers generally must perform switching studies that provide evidence that patients who use first the originator or biosimilar and then switch to the other do not experience higher rates of adverse events or decreased efficacy.