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Voyxact

Voyxact® (sibeprenlimab-szsi) is an FDA-approved prescription medicine used to reduce proteinuria (protein in the urine) in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. This approval is under the FDA’s accelerated approval pathway, based on the reduction of proteinuria. Its long-term impact on slowing kidney function decline is still being studied in confirmatory trials.

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 :

    Sibeprenlimab-Szsi
  • Innovator :

    OTSUKA PHARM CO LTD
  • Approval Date :

    25-Nov-25
  • Data Exclusivity Expiry :

    25-Nov-29
  • Market Exclusivity Expiry :

    25-Nov-37
  • Dosage Form :

    Injection
  • Strength :

    400MG/2ML(200MG/ML)
  • Therapeutic Category :

    Immunomodulator
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    NA
  • 2026 :

    135
  • 2027 :

    447
  • 2028 :

    837
  • 2029 :

    1,232
  • 2030 :

    1,646
  • 2031 :

    1,951
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