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Insulin glargine biosimilar - Biocon

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Drug Profile

Insulin glargine biosimilar - Biocon

Alternative Names: Basalog; bGlargine; GALACTUS; Glaricon; insulin glargine-yfgn injection - Biocon; MYL-1501D; Semglee

Latest Information Update: 29 Aug 2025

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At a glance

  • Originator Biocon
  • Developer Abdi Ibrahim Remede Pharma; Biocon; PiSA Farmaceutica; Viatris Inc
  • 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Type 1 diabetes mellitus; Type 2 diabetes mellitus

Most Recent Events

  • 22 Jul 2024 Biocon Sdn plans phase I bioequivalence trial in Type 1 diabetes mellitus (SC) (CTIS2023-504509-36-00) (EUCT-2023-504509-36-00)
  • 03 Aug 2023 Launched for Type 1 diabetes mellitus (In adolescents, In children, In adults) in Singapore, Spain, Portugal, Netherlands, Denmark, Germany, Poland (SC) (Biocon website, August 2023)
  • 03 Aug 2023 Launched for Type 1 diabetes mellitus in Mexico, Canada (SC) (Biocon website, August 2023)

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