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Teriparatide biosimilar - Accord Healthcare

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Drug Profile

Teriparatide biosimilar - Accord Healthcare

Alternative Names: SONDELBAY

Latest Information Update: 17 Feb 2022

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At a glance

  • Originator Accord Healthcare
  • Class Diagnostic agents; Osteoporosis therapies; Peptide hormones; Skin disorder therapies
  • Mechanism of Action Parathyroid hormone replacements
  • 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

  • Preregistration Osteoporosis

Most Recent Events

  • 28 Jan 2022 Preregistration for Osteoporosis in European Union (SC)
  • 28 Jan 2022 Accord Healthcare re-submits marketing authorization application of teriparatide biosimilar in Osteoporosis in the EU, prior to January 2022
  • 28 Jan 2022 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopts a positive opinion and recommends marketing authorization of teriparatide biosimilar in Osteoporosis in the EU

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