Insulin glargine biosimilar - Samsung Bioepis/Fresenius Kabi

Drug Profile

Insulin glargine biosimilar - Samsung Bioepis/Fresenius Kabi

Alternative Names: Lusduna; LUSDUNA Nexvue; MK 1293; SB 9

Latest Information Update: 21 Dec 2017

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At a glance

  • Originator Samsung Bioepis
  • Developer Fresenius Kabi; Samsung Bioepis
  • Class Antihyperglycaemics; Insulins; Pancreatic hormones
  • Mechanism of Action Insulin receptor agonists; Ornithine decarboxylase stimulants; Phosphokinase stimulants; Protein tyrosine kinase stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Registered Diabetes mellitus
  • Preregistration Type 1 diabetes mellitus; Type 2 diabetes mellitus

Most Recent Events

  • 20 Jul 2017 FDA issues tentative approval to insulin glargine biosimilar for Type-1 diabetes mellitus and Type-2 diabetes mellitus in USA
  • 04 Jan 2017 Registered for Diabetes mellitus in European Union, Iceland, Norway, Liechtenstein (SC)
  • 16 Sep 2016 Sanofi files a patent infringement suit against Merck Sharp & Dohme in the US District Court for the District of Delaware
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