EMA — authorised 19 April 2024
- Application: EMEA/H/C/006183
- Marketing authorisation holder: Samsung Bioepis NL B.V.
- Local brand name: Pyzchiva
- Indication: Crohn’s DiseasePyzchiva 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 psoriasisPyzchiva 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) (s
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) approved Pyzchiva, a biosimilar, for the treatment of several conditions. Pyzchiva is indicated for adult patients with moderately to severely active Crohn's disease 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.