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Improved Insurance Coverage Increased Biosimilar Semglee's Market Share After The FDA's Interchangeability
Pragya Kakani1, Bradley A Katcher2, Luca Maini3
1Pragya Kakani (pka4006@med.cornell.edu), Cornell University, New York, New York.
Health Affairs (Project Hope)
|November 3, 2025
Summary
The Food and Drug Administration
Area of Science:
- Pharmacoeconomics and Health Services Research
- Biopharmaceutical Market Analysis
- Drug Policy and Regulation
Background:
- The U.S. Food and Drug Administration (FDA) designation of interchangeability allows pharmacists to substitute biosimilars for originator products.
- Biosimilar interchangeability is intended to drive adoption, but its real-world impact on market share remains under-examined.
- Semglee (insulin glargine-yfgn) is a biosimilar to Lantus (insulin glargine), a widely used long-acting insulin.
Purpose of the Study:
- To investigate the relationship between FDA interchangeability designation and biosimilar adoption for Semglee.
- To analyze the impact of interchangeability on Semglee's market share in Medicaid and employer-sponsored insurance markets.
- To assess the influence of insurance coverage and state substitution laws on biosimilar uptake.
Main Methods:
- An interrupted time-series analysis was employed to evaluate market share changes.
- Data were collected for the Medicaid and employer-sponsored insurance markets during 2021-2022.
- The study period included the period before and after Semglee achieved interchangeability in July 2021.
Main Results:
- Semglee's market share increased by 3.70% in Medicaid and 19.25% in employer-sponsored insurance post-interchangeability.
- Market share gains coincided with improved Semglee insurance coverage, particularly in employer plans.
- State-level variations in pharmacist substitution laws did not correlate with Semglee adoption.
Conclusions:
- Biosimilar adoption following interchangeability designation appears primarily driven by enhanced insurance coverage.
- Pharmacist substitution and increased prescribing alone played minimal or secondary roles in Semglee's market share growth.
- Relaxing federal interchangeability requirements could potentially enhance biosimilar adoption rates.
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