EMA — authorised 22 August 2024
- Application: EMEA/H/C/005918
- Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
- Local brand name: Steqeyma
- Indication: Crohn’s Disease Steqeyma is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Plaque psoriasis Steqeyma is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) approved STEQEYMA, a biosimilar, for the treatment of various conditions. STEQEYMA is indicated for the treatment of moderately to severely active Crohn's disease in adults who have had an inadequate response to conventional therapy or a TNFα antagonist. It is also approved for the treatment of moderate to severe plaque psoriasis in adults and children aged 6 years and older, as well as active psoriatic arthritis in adult patients.