Mylan-Biocon’s insulin biosimilar faces FDA hurdle - (The Economic Times via NewsPoints Desk)

  • 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.

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