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Elfabrio

Elfabrio is the first PEGylated enzyme replacement therapy approved by the FDA for adults with Fabry disease. It provides exogenous alpha‑galactosidase A to reduce globotriaosylceramide accumulation and improve organ function.

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 :

    Pegunigalsidase Alfa-Iwxj

  • Innovator :

    PROTALIX BIOTHERAPEUTICS, INC.

  • Approval Date :

    09-May-23

  • Data Exclusivity Expiry :

    09-May-27

  • Market Exclusivity Expiry :

    09-May-35

  • Dosage Form :

    Injection

  • Strength :

    20mg/10ml

  • Therapeutic Category :

    Antimetabolic Disorder

  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    29

  • 2026 :

    NA

  • 2027 :

    NA

  • 2028 :

    NA

  • 2029 :

    NA

  • 2030 :

    50

  • 2031 :

    NA
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