EMA — authorised 25 September 2024
- Application: EMEA/H/C/006544
- Marketing authorisation holder: Fresenius Kabi Deutschland GmbH
- Local brand name: Otulfi
- Indication: Plaque psoriasisOtulfi 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 A). Paediatric plaque psoriasisOtulfi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA)Otul
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) has approved OTULFI, a biosimilar, for the treatment of several inflammatory conditions. OTULFI is indicated for moderate to severe plaque psoriasis in adults and children aged 6 years and older, as well as for active psoriatic arthritis in adults. Additionally, OTULFI is approved for the treatment of moderately to severely active Crohn's disease in adults and children weighing at least 40 kg. These indications are for patients who have failed to respond to, or are intolerant to, other systemic therapies or phototherapies.