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Niktimvo

Niktimvo is an IV antibody treatment for adults and children (≥ 40 kg) with chronic graft‑versus‑host disease whose condition worsened despite at least two prior therapies. It works by blocking CSF‑1R to calm overactive immune cells and reduce symptoms.

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 :

    Axatilimab-Csfr
  • Innovator :

    INCYTE CORPORATION
  • Approval Date :

    14-Aug-24
  • Data Exclusivity Expiry :

    14-Aug-28
  • Market Exclusivity Expiry :

    14-Aug-36
  • Dosage Form :

    Intravenous Infusion
  • Strength :

    50mg/ml , 9mg/0.18ml and 22mg/0.44 ml
  • Therapeutic Category :

    Immunomodulators
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    103
  • 2026 :

    201
  • 2027 :

    312
  • 2028 :

    432
  • 2029 :

    533
  • 2030 :

    629
  • 2031 :

    698
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