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Agalsidase beta biosimilar - Bio Sidus S.A.

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Drug Profile

Agalsidase beta biosimilar - Bio Sidus S.A.

Alternative Names: AGA BETA BS; Recombinant human alpha galactosidase A - Bio Sidus S.A.

Latest Information Update: 24 Apr 2025

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At a glance

  • Originator Bio Sidus S.A.
  • Developer Biosidus S.A.
  • Class Galactosidases; Glycoproteins; Isoenzymes; Recombinant proteins
  • Mechanism of Action Alpha-galactosidase 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

  • Phase III Fabry's disease

Most Recent Events

  • 16 Apr 2025 Biosidus announces intention to launch agalsidase beta biosimilar for Fabry's disease in Argentina by the middle of 2025
  • 13 Dec 2022 Phase-III clinical trials in Fabry's disease in Argentina (Parenteral) (NCT05843916)
  • 17 Apr 2022 Bio Sidus S.A. completes a phase I trial in Fabry's disease (In volunteers) in Argentina (IV, infusion) (NCT05343715)

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