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Zynyz

Zynyz is the first PD‑1 inhibitor approved by the FDA for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. It is now available both as monotherapy and in combination with platinum‑based chemotherapy, and is also approved for metastatic Merkel cell carcinoma; it enhances T‑cell activity to target and slow tumor growth.

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 :

    Retifanlimab-Dlwr
  • Innovator :

    INCYTE
  • Approval Date :

    22-Mar-23
  • Data Exclusivity Expiry :

    22-Mar-27
  • Market Exclusivity Expiry :

    22-Mar-35
  • Dosage Form :

    Intravenous Injection
  • Strength :

    500mg/20ml
  • Therapeutic Category :

    Anticancer
  • Revenue ($M) :

    3

Year-wise Projected Sales ($M) :

  • 2025 :

    19
  • 2026 :

    55
  • 2027 :

    99
  • 2028 :

    134
  • 2029 :

    166
  • 2030 :

    198
  • 2031 :

    223
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