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Biocon And Mylan Get CRL From FDA For Lantus Rival

Executive Summary

Biocon has run into fresh trouble with the US Food and Drug Administration after receiving a complete response letter on its application for insulin glargine, a proposed rival to Sanofi’s top-selling Lantus biologic. 

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Biocon and Mylan press ahead with plans to broaden patient access in the US to biosimilar pegfilgrastim and are enthused with the initial uptake for their trastuzumab biosimilar ahead of more upcoming competition. A mid-2020 US launch for partnered insulin glargine is also on course.

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Strong growth in Biocon's biologics segment continued in the second quarter and the vertical has now set a target of $1bn in annual sales by the 2021-22 fiscal year.

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