Improved Insurance Coverage Increased Biosimilar Semglee's Market Share After The FDA's Interchangeability Designation

Interchangeability, a Food and Drug Administration (FDA) designation allowing pharmacists to substitute a biosimilar for its branded originator at the point of sale, is intended to increase biosimilar adoption. However, little is known about the relationship between interchangeability and biosimilar...

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Vydáno v:	Health affairs (Millwood, Va.) Ročník 44; číslo 11; s. 1417
Hlavní autoři:	Kakani, Pragya, Katcher, Bradley A, Maini, Luca
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 01.11.2025
Témata:	Biosimilar Pharmaceuticals - economics Biosimilar Pharmaceuticals - therapeutic use Health Benefit Plans, Employee - statistics & numerical data Humans Insurance Coverage - statistics & numerical data Interrupted Time Series Analysis Medicaid - statistics & numerical data United States United States Food and Drug Administration United States
ISSN:	2694-233X, 2694-233X
On-line přístup:	Zjistit podrobnosti o přístupu
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Shrnutí:	Interchangeability, a Food and Drug Administration (FDA) designation allowing pharmacists to substitute a biosimilar for its branded originator at the point of sale, is intended to increase biosimilar adoption. However, little is known about the relationship between interchangeability and biosimilar adoption. We conducted an interrupted time-series analysis to examine this relationship for Semglee, which gained interchangeability in July 2021, in Medicaid and the employer-sponsored insurance market in 2021-22. Semglee is a biosimilar for Lantus (insulin glargine), the most-prescribed long-acting insulin in the US. We found that Semglee market share increased by 3.70 percentage points in Medicaid and 19.25 percentage points in employer-sponsored insurance beginning in the first quarter of 2022, coinciding with improved Semglee coverage, especially in employer-sponsored insurance. State-level variation in pharmacist substitution laws was not associated with Semglee adoption. These results suggest that increased adoption was mediated mainly through improved insurance coverage, with no detectable role for increased prescribing alone and only a secondary role, at most, for pharmacist substitution. Semglee's gains in market share after interchangeability suggest that easing of federal interchangeability requirements may moderately spur biosimilar adoption.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2694-233X 2694-233X
DOI:	10.1377/hlthaff.2025.00443