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Andembry

Andembry is a preventive therapy for hereditary angioedema (HAE) in adults and adolescents 12+ years. This selective Factor XIIa inhibitor targets the top of the inflammatory cascade with once-monthly dosing. FDA-approved in June 2025, offering the first monthly prophylactic HAE treatment targeting Factor XIIa.

The information outlined in the molecule details section below would help you plan aBLA development early to enable a streamlined and competitive biosimilar strategy.

Molecule Details :

  • Molecule Name :

    Garadacimab-Gxii
  • Innovator :

    CSL BEHRING LLC
  • Approval Date :

    16-Jun-25
  • Data Exclusivity Expiry :

    16-Jun-29
  • Market Exclusivity Expiry :

    16-Jun-37
  • Dosage Form :

    Subcutaneous Injection
  • Strength :

    200MG/1.2ML
  • Therapeutic Category :

    Hereditary Angioedema Agents
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    129
  • 2026 :

    202
  • 2027 :

    256
  • 2028 :

    364
  • 2029 :

    501
  • 2030 :

    531
  • 2031 :

    567
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