Merck & Co.’s Follow-On Insulin Application Accepted by FDA

The US Food and Drug Administration (FDA) has accepted Merck & Co.'s new drug application (NDA) for MK-1293, an investigational follow-on biologic of insulin glargine, a long-acting insulin, for people with Type 1 and Type 2 diabetes being developed by Merck with partial funding from Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen.

The drug will compete against Lantus (insulin glargine), Sanofi's top-selling drug with 2015 global sales of EUR 6.390 billion ($7.103 billion), which is facing generic competition. Sanofi is repositioning itself with its next-generation insulin glargine, Toujeo, which gained marketing authorization in the three major markets (US, European Union, and Japan) in 2015 and is now approved in 20 countries overall. Some analysts peg Toujeo as a potential blockbuster drug. A Thomson Reuters analysis projects Toujeo sales to reach $1.299 billion in 2019.

In 2015, the FDA approved Eli Lilly and Company’s Basaglar (insulin glargine injection) 100 units/mL. Basaglar is a long-acting insulin with an identical amino acid sequence to Lantus, another U-100 insulin glargine. Per Lilly’s settlement agreement with Sanofi, Basaglar became e available in the US starting on December 15, 2016. Basaglar is part of the Boehringer Ingelheim and Lilly diabetes alliance.

Source: Merck & Co.

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