Ustekinumab biosimilar - Bio-Thera Solutions
Alternative Names: BAT-2206; STARJEMZA; ustekinumab-hmnyLatest Information Update: 25 Jun 2025
At a glance
- Originator Bio-Thera Solutions
- Class Anti-inflammatories; Antipsoriatics; Antirheumatics; Antiulcers; Monoclonal antibodies; Skin disorder therapies
- Mechanism of Action Interleukin 12 inhibitors; Interleukin 23 inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes - Autoimmune disorders
Highest Development Phases
- Registered Crohn's disease; Plaque psoriasis; Psoriatic arthritis; Ulcerative colitis
- No development reported Autoimmune disorders
Most Recent Events
- 20 Jun 2025 Bio-Thera Solutions receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends approval of ustekinumab biosimilar for Plaque psoriasis
- 27 May 2025 Registered for Crohn's disease in USA (IV)
- 27 May 2025 Registered for Crohn's disease in USA (SC)