Insulin biosimilars are a type of follow-on biologic medication designed to be highly similar to an already approved biological product, known as the reference product. For insulin, the reference products are recombinant human insulins that have been available for many years to treat diabetes, such as Humalog, Novolog, Lantus, and Levemir. Biosimilars are developed to have no clinically meaningful differences from the reference product in terms of safety, purity, and potency. However, there may be minor differences in clinically inactive components or aspects of production processes.
Approval Process for Insulin Biosimilars
In the United States, the Biologics Price Competition and Innovation Act of 2009 created an approval pathway for biosimilar and interchangeable products. To gain FDA approval, a biosimilar manufacturer must demonstrate its product is highly similar to the reference product based on extensive analytical, animal, and clinical testing. Phase 1 and Phase 3 clinical trials are required to prove bio similarity in terms of safety, purity, and potency. The totality of evidence must show there are no clinically meaningful differences that could impact the safety or effectiveness of the biosimilar compared to the reference product.
If approved as interchangeable, the biosimilar could automatically be substituted for the reference product without involvement of the prescriber. Additional switching studies are needed to gain interchangeable approval.
Potential Cost Savings of Insulin Biosimilars
One of the key expectations of approving biosimilar pathways is to create market competition that could help lower drug prices over time. Brand name prescription insulin products have risen dramatically in price in recent decades. A vial ofHumalog that cost $21 in 1996 was priced at $234 by 2019. High and rising insulin prices have created major barriers to care for millions of Americans with diabetes.
The entrance of biosimilar insulins in the market creates opportunities for more treatment options at potentially lower costs. Cost savings occur through competition as biosimilar manufacturers can price their products at a discount to the reference product while achieving similar profit margins. Studies project insulin biosimilars could reduce overall insulin spending in the United States by $5.5-$8.8 billion over 5 years if 20-30% market shares were gained by 2024. Lower prices would expand access to life-saving insulin treatment.
Approved Insulin Biosimilars and Future Pipeline
The first insulin approved in the United States was Interchangable Insulin Aspart, marketed under the name Semglee. Approved in July 2020, it is interchangeable with Novolog and produced by Viatris. Another insulin aspart biosimilar called Insulin Aspart (Insuman), made by Eli Lilly and marketed by Boehringer Ingelheim, received FDA approval in December 2021.
Several other insulin are in Phase 3 clinical trials. Lusduna, a Semglee follow-on produced by Mylan, is being tested as interchangeable with Novolog. Insulin glargine biosimilars followed by Mylan, Coherus, and Novo Nordisk are close to filing for FDA approval as well. Insulin lispro and insulin degludec biosimilars are also in development. If approved, availability of multiple interchangeable biosimilar options would create the most market competition to help lower prices.
Impact on Diabetes Management and Treatment
While brand name insulin costs have severely burdened many patients, biosimilar entry has the potential to transform diabetes treatment affordability in America. Widespread biosimilar use could result in total out-of-pocket costs being cut in half for some patients. The substantial price reductions versus originator products make them an important new tool for managing diabetes costs on both individual and national health expenditure levels.
At the same time, clinical experience is still building as more patients gain access to approved biosimilars. Post-marketing studies will continue evaluating immunogenicity, safety, and efficacy over long-term use. Physicians and patients also adapt to incorporating biosimilars into standard care regimens. Overall, availability of multiple, competitively priced insulin biosimilar options stands to vastly improve diabetes treatment outcomes through expanded access and compliance made possible by more affordable insulin options.
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