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Insulin glargine biosimilar - HEC Pharm

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Drug Profile

Insulin glargine biosimilar - HEC Pharm

Alternative Names: HEC-glargine

Latest Information Update: 19 Jan 2025

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At a glance

  • Originator HEC Pharm
  • 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

  • Phase II/III Diabetes mellitus

Most Recent Events

  • 19 Jan 2025 Insulin glargine biosimilar is still in phase-II/III clinical trials in Diabetes mellitus in South Africa (SC) (HEC Pharm pipeline, January 2024)
  • 04 Jan 2023 Lannett announces intention to submit Biologics License Application (BLA), under the the 351(k) biosimilar pathway, to the US FDA for Diabetes mellitus in mid-year 2023
  • 31 Aug 2022 Lannett completes a phase I trial in Diabetes mellitus (In volunteers) in South africa (NCT05248841)

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