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There’s only one Lantus®

According to the FDA, there’s currently no therapeutic equivalent to insulin glargine U1001

  • A follow-on biologic is similar but not identical to the listed, or innovator, product1-4
  • Currently, there are no FDA-approved AB/AP-rated follow-on biologic insulins1
  • No products are currently licensed to be interchangeable with, or generics for, Lantus®1-3
  • Follow-on biologic insulin is not a generic2

AB, meets necessary bioequivalence requirements; AP, injectable aqueous solutions.

aIndividual state pharmacy dispensing laws regarding biosimilars substitution may vary.

In general, a pharmacy cannot automatically substitute any follow-on biologic for a prescribed brand.2,3,a

More info on follow-on biologics +
  1. Drugs@FDA/Drug Details: Accessed August 18, 2017.
  2. FDA approves Basaglar®, the first “follow-on” insulin glargine product to treat diabetes. U.S. Food and Drug Administration website. Published December 16, 2015. Accessed August 18, 2017.
  3. Information for consumers (biosimilars). U.S. Food and Drug Administration website. Updated August 27, 2015. Accessed August 18, 2017.
  4. Johnson JA. FDA Regulation of Follow-On Biologics. Congressional Research Service. April 26, 2010:1-18.