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FDA approves Semglee—MYL’s Lantus biosimilar:

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DewDiligence Member Level  Friday, 06/12/20 10:19:35 AM
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FDA approves Semglee—MYL’s Lantus biosimilar:

https://www.prnewswire.com/news-releases/mylan-and-biocon-announce-us-fda-approval-of-semglee-insulin-glargine-injection-301074847.html
Quote:
Favorable judgments on all remaining patent claims asserted by Sanofi against Mylan's insulin glargine products have been obtained. Although Sanofi may seek certain appeals of those judgments, Mylan is confident they will not affect commercialization plans.

Sanofi's total IQVIA sales for the 12 months ending April 30, 2020 were approximately $1.68 billion for Lantus 100 Units/mL Vial and approximately $4.33 billion for Lantus SoloSTAR Pen [i.e. $6.2B in all].

Mylan and Biocon Biologic's insulin glargine has received regulatory approval in more than 45 countries around the world and is the third product approved by FDA through the Mylan-Biocon Biologics collaboration.



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