The FDA has cited issues with Mylan's application seeking approval for generic versions of insulin glargine, which is sold by Sanofi as Lantus, reported The Economic Times.
In its complete response letter (CRL), the agency sought clarifications from Mylan and partner Biocon about a change in the manufacturing site for glargine from Bengaluru to a new facility in Malaysia.
Last year, insulin glargine generated about $7 billion in global sales, the news source said.
Mylan and Biocon said the CRL was anticipated and built into their plan for the submission of insulin glargine.
"Together, Mylan and Biocon are already executing on all required activities we had agreed upon with the FDA, and they are progressing according to plan," the statement said.
Mylan added that it does not anticipate any impact to the previously communicated timing of approval and anticipated launch of the biosimilar.
To read more NewsPoints articles, click here.