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Denosumab biosimilar - Alkem Laboratories

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Drug Profile

Denosumab biosimilar - Alkem Laboratories

Alternative Names: ENZ-215

Latest Information Update: 28 Mar 2025

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At a glance

  • Originator Alkem Laboratories
  • Developer Alkem Laboratories; Enzene Biosciences
  • Class Antihypercalcaemics; Antineoplastics; Antirheumatics; Calcium regulators; Immunotherapies; Monoclonal antibodies; Osteoporosis therapies
  • Mechanism of Action RANK ligand inhibitors
  • 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 III Postmenopausal osteoporosis

Most Recent Events

  • 28 Mar 2025 No recent reports of development identified for phase-I development in Postmenopausal-osteoporosis(In volunteers) in United Kingdom (SC, Injection)
  • 07 Mar 2022 Phase-III clinical trials in Postmenopausal osteoporosis (In adults, In the elderly) in Bulgaria, Czech Republic, Denmark, Lithuania, Poland, Serbia and Spain (SC,Injection) (EudraCT2021-004811-26)
  • 18 Feb 2022 Phase-I clinical trials in Postmenopausal osteoporosis (In volunteers) in UK (SC) (NCT05245669)

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