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Keytruda Qlex

Keytruda Qlex is an FDA-approved subcutaneous formulation of Keytruda developed by Merck & Co. It contains the active immunotherapy molecule pembrolizumab, a PD-1 immune checkpoint inhibitor, combined with berahyaluronidase alfa, an enzyme that enables rapid subcutaneous delivery.

Unlike the traditional intravenous (IV) infusion of Keytruda administered over 30 minutes, Keytruda Qlex is given as a 1- or 2-minute subcutaneous injection every 3 or 6 weeks. Clinical studies in advanced non–small cell lung cancer (NSCLC) demonstrated comparable drug exposure and consistent safety between Keytruda Qlex and IV Keytruda, offering patients a faster administration option while maintaining therapeutic effectiveness.

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 :

    Pembrolizumab And Berahyaluronidase Alfa-Pmph
  • Innovator :

    MERCK SHARP & DOHME LLC
  • Approval Date :

    19-Sep-25
  • Data Exclusivity Expiry :

    19-Sep-29
  • Market Exclusivity Expiry :

    19-Sep-37
  • Dosage Form :

    Subcutaneous Injection
  • Strength :

    395MG/4800UNITS(2.4ML) and 790MG/9600UNITS(4.8ML)
  • Therapeutic Category :

    PD-1 Inhibitor
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    26
  • 2026 :

    2,735
  • 2027 :

    6,906
  • 2028 :

    9,232
  • 2029 :

    10,401
  • 2030 :

    9,678
  • 2031 :

    9,469
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