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# FDA Nixes Mylan/Biocon Lantus Biosimilar
- URL: https://www.fdaweb.com/fda-nixes-mylan-biocon-lantus-biosimilar/
- Published: 2018-06-06T12:00:00.000Z
- Updated: 2026-09-15T00:11:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141618

FDA has issued a complete response letter to Mylan and its partner Biocon on their application for a biosimilar citing Sanofi’s Lantus (insulin glargine) injection. The Center for Biosimilars [reports](http://www.centerforbiosimilars.com/news/fda-rejects-mylan-and-biocons-followon-insulin-glargine?ref=fdaweb.com) that Mylan informed it that the letter had been expected and that the company had agreed to give the agency additional clinical data in support of a manufacturing site change from Bangalore to Malaysia.

The report says the letter comes after Biocon was issued an FDA-483 with six inspection observations for its Malaysia manufacturing facility.