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Imaavy

Imaavy is an IV antibody for adults and teens aged 12 and older with generalized myasthenia gravis who test positive for AChR or MuSK antibodies. It targets and blocks the FcRn receptor to reduce harmful autoantibodies and improve muscle strength.

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 :

    Nipocalimab-Aahu

  • Innovator :

    JANSSEN BIOTECH, INC.

  • Approval Date :

    29-Apr-25

  • Data Exclusivity Expiry :

    29-Apr-29

  • Market Exclusivity Expiry :

    29-Apr-37

  • Dosage Form :

    Injection

  • Strength :

    300MG/1.62ML and 1200MG/6.5ML

  • Therapeutic Category :

    Immunomodulators

  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    413

  • 2026 :

    1,031

  • 2027 :

    1,547

  • 2028 :

    2,011

  • 2029 :

    2,514

  • 2030 :

    3,016

  • 2031 :

    3,469
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