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Omalizumab biosimilar - Kashiv BioSciences

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Drug Profile

Omalizumab biosimilar - Kashiv BioSciences

Alternative Names: ADL-018; AVT-23

Latest Information Update: 14 Oct 2025

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At a glance

  • Originator Adello Biologics
  • Developer Alvotech; Amneal Pharmaceuticals; Kashiv BioSciences
  • Class Anti-inflammatories; Antiallergics; Antiasthmatics; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action IgE receptor antagonists; Immunosuppressants
  • 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
  • Available For Licensing Yes - Asthma

Highest Development Phases

  • Preregistration Asthma; Chronic urticaria; Food hypersensitivity; Rhinosinusitis

Most Recent Events

  • 06 Oct 2025 The European Medicines Agency accepts Marketing Authorization Application for Omalizumab biosimilar for Rhinosinusitis, Asthma and Chronic-urticaria for review
  • 06 Oct 2025 Preregistration for Asthma in European Union (SC)
  • 06 Oct 2025 Preregistration for Chronic-urticaria in European Union (SC)

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