Printed From:

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 +
References
  1. Drugs@FDA/Drug Details: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021081. 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. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm477734.htm. Published December 16, 2015. Accessed August 18, 2017.
  3. Information for consumers (biosimilars). U.S. Food and Drug Administration website. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm241718.htm. 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.