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Ustekinumab biosimilar - Formycon

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Drug Profile

Ustekinumab biosimilar - Formycon

Alternative Names: FYB 202; Fymskina; Otulfi; Ustekinumab-aauz

Latest Information Update: 12 Jan 2026

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At a glance

  • Originator Formycon
  • Developer Formycon; Fresenius Kabi
  • Class Anti-inflammatories; Antipsoriatics; Antirheumatics; Antiulcers; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Interleukin 12 inhibitors; Interleukin 23 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Crohn's disease; Plaque psoriasis; Psoriatic arthritis; Ulcerative colitis
  • Registered Immunological disorders

Most Recent Events

  • 06 Jan 2026 Fresenius Kabi receives approval for new dose 45 mg/0.5 mL single-dose vial for subcutaneous injection from the FDA for ustekinumab-aauz
  • 03 Nov 2025 Fresenius Kabi plans a phase-I Bioequivalence trial (In volunteers) in Poland (Parenteral), (CTIS2025-522422-13-00)
  • 02 Jul 2025 Formycon announces intention to launch ustekinumab biosimilar to in Germany in Q3 of 2025

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