Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing approval from both the European Commission (which applies to all 28 European Union member states) and the European Economic Area member states of Norway, Iceland, and Liechtenstein.[1] Additionally, the Therapeutic Goods Administration approved the biosimilar for use

Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection LusdunaTM NexvueTM,  a follow-on biologic to Sanofi’s Lantus®.  Because Merck’s application for insulin glargine was filed using the abbreviated 505(b)(2) regulatory pathway provided by the Hatch-Waxman Amendments (not a section (k) application