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# Merck Files NDA for ‘Follow On’ Lantus Product
- URL: https://www.fdaweb.com/merck-files-nda-for-follow-on-lantus-product/
- Published: 2016-08-05T12:00:00.000Z
- Updated: 2026-09-14T21:21:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136427

FDA has accepted a Merck NDA for MK-1293, an investigational follow-on biologic copy of Sanofi-Aventis’ Lantus (insulin glargine) for use in treating people with Type 1 and Type 2 diabetes. Because Lantus was not approved under the Public Health Service Act, there is no biosimilar approval pathway for the product. In other parts of the world, the submission would be considered a biosimilar, according to Merck. The 505(b)(2) NDA submission for MK-1293 includes [results of two Phase 3 studies](http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.mercknewsroom.com%2Fnews-release%2Fresearch-and-development-news%2Fmercks-investigational-insulin-glargine-mk-1293-met-prima&esheet=51396386&newsitemid=20160805005285&lan=en-US&anchor=results+of+two+Phase+3+studies&index=1&md5=a406e48e828cf30438ca110b313b8ec3&ref=fdaweb.com), one conducted in people with Type 1 diabetes, and one in Type 2 diabetes; Lantus was the active comparator in both studies.