Tagged as: Insulin Glargine

CVS Replaces Lantus® With Basaglar®

It has been reported that U.S. pharmacy benefit manager CVS will drop Sanofi’s insulin drugs, Lantus® (insulin glargine injection, 100 units/ml) and Toujeo® (insulin glargine injection, 300 units/ml) from the list of medications for which it reimburses on behalf of health insurers.  In July CVS caremark® published a list of…

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Biosimilar Market Update – Biocon Biologics LTD and Samsung Bioepis

Last week, Biocon Ltd announced the approval of approximately a 150 million USD capital injection from Goldman Sachs.  Dr. Christian Hamacher, CEO, Biocon Biologics, said, “This capital injection by Goldman Sachs will enable us to make prudent investments in R&D, high-quality manufacturing, as well as, establish a global commercial footprint.” …

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Mylan and Biocon Announce U.S. Launch of Insulin Glargine Biosimilar

We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection).  Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market.  SEMGLEE is a biosimilar of LANTUS, Sanofi’s long-acting insulin glargine product.  SEMGLEE will be available in vials and pre-filled pens.  The lead…

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PTAB Issues Final Written Decisions Finding Most Claims of Sanofi’s Lantus Patents Invalid

As we previously reported, Mylan filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection).  On May 29, 2020, the PTAB issued Final Written Decisions in eight of Mylan’s pending petitions concerning four patents finding most of the challenged claims…

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Clinical Trial Announcements

This week, several companies reported updates in their clinical development of biosimilars or follow-on biologics. On December 3, Outlook Therapeutics (formerly known as Oncobiologics) announced the FDA agreed with three of Outlook’s proposed Special Protocol Assessments (“SPAs”) relating to ONS-5010, an investigational ophthalmic formulation of bevacizumab which is currently in…

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