Marketing authorisations
EMA — authorised 5 January 2024
- Application: EMEA/H/C/006101
- Marketing authorisation holder: Stada Arzneimittel AG
- Local brand name: Uzpruvo
- Indication: Plaque psoriasisUzpruvo 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 psoriasisUzpruvo is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Psoriatic arthritis (PsA)Uzpruvo,
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) approved Uzpruvo (IL-23 Therapy) for the treatment of various inflammatory conditions. The medication is indicated for moderate to severe plaque psoriasis in adults and children aged 6 years and older, who have failed to respond to or are intolerant to other systemic therapies. It is also approved for the treatment of active psoriatic arthritis in adults and moderately to severely active Crohn's disease in adults and children weighing at least 40 kg, who have had an inadequate response to conventional or biologic therapy.
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EMA — authorised 20 June 2024
- Application: EMEA/H/C/006132
- Marketing authorisation holder: Amgen Technology (Ireland) UC
- Local brand name: Wezenla
- Indication: Crohn’s diseaseWezenla 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. Pediatric Crohn's diseaseWezenla is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.Plaque psoriasisWezenla is ind
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) has approved Wezenla (IL-23 Therapy) for the treatment of certain inflammatory conditions. Wezenla is indicated for adult patients with moderately to severely active Crohn's disease who have not responded to conventional therapy or TNFα antagonists. It is also approved for the treatment of plaque psoriasis in adults and children aged 6 years and older, as well as psoriatic arthritis in adults. The marketing authorisation was granted to Amgen Technology (Ireland) UC on 20 June 2024.
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EMA — authorised 12 September 2024
- Application: EMEA/H/C/006448
- Marketing authorisation holder: Samsung Bioepis NL B.V.
- Local brand name: Eksunbi
- Indication: Crohn’s DiseaseEksunbi 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.Ulcerative colitisEksunbi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such
- Pathway: biosimilar
- Status: withdrawn
The European Medicines Agency (EMA) has approved Eksunbi (IL-23 Therapy) for the treatment of adult patients with moderately to severely active Crohn's disease, ulcerative colitis, and plaque psoriasis. Additionally, Eksunbi is indicated for the treatment of psoriatic arthritis in adult patients. This approval was granted under the biosimilar expedited pathway.
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EMA — authorised 25 September 2024
- Application: EMEA/H/C/005805
- Marketing authorisation holder: Formycon AG
- Local brand name: Fymskina
- Indication: Plaque psoriasisFymskina 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 psoriasisFymskina 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)F
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) approved Fymskina (IL-23 Therapy) for the treatment of various inflammatory conditions. Fymskina is indicated for moderate to severe plaque psoriasis in adults and children aged 6 years and older, who have failed to respond to or are intolerant to other systemic therapies. It is also approved for the treatment of active psoriatic arthritis in adults and moderately to severely active Crohn's disease in adults who have had an inadequate response to conventional therapy or a TNFα antagonist.
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EMA — authorised 12 December 2024
- Application: EMEA/H/C/006585
- Marketing authorisation holder: Accord Healthcare S.L.U.
- Local brand name: Absimky
- Indication: Plaque psoriasis ABSIMKY 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 psoriasis ABSIMKY is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) ABS
- Pathway: biosimilar
- Status: withdrawn
The European Medicines Agency (EMA) has approved Absimky (IL-23 Therapy) for the treatment of several chronic inflammatory diseases. Absimky is indicated for the treatment of moderate to severe plaque psoriasis in adults and children aged 6 years and older who have failed to respond to or are intolerant to other systemic therapies. It is also approved for the treatment of active psoriatic arthritis in adults, Crohn's disease in adults, and ulcerative colitis in adults who have had an inadequate response to conventional therapies or biologics. The marketing authorisation was granted to Accord Healthcare S.L.U. through the biosimilar expedited pathway.
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EMA — authorised 14 February 2025
- Application: EMEA/H/C/006444
- Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
- Local brand name: Yesintek
- Indication: Plaque psoriasisYesintek 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 psoriasisYesintek is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA)Yesi
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) has granted marketing authorisation for Yesintek (IL-23 Therapy) for the treatment of moderate to severe plaque psoriasis in adults and children aged 6 years and older. Yesintek is also indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy. Additionally, Yesintek is approved for the treatment of moderately to severely active Crohn's disease in adult patients who have had an inadequate response to conventional therapy or a TNFα antagonist.
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EMA — authorised 2 June 2025
- Application: EMEA/H/C/006649
- Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
- Local brand name: Qoyvolma
- Indication: Adult Crohn’s Disease Qoyvolma 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. Paediatric Crohn's Disease Qoyvolma is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Ulcerative colitis Qoyvolma is
- Pathway: biosimilar
- Status: approved
On 2 June 2025, the European Medicines Agency (EMA) granted marketing authorisation for Qoyvolma (IL-23 Therapy) for the treatment of adult and paediatric patients with moderately to severely active Crohn's disease, ulcerative colitis, and plaque psoriasis. Qoyvolma is also indicated for the treatment of active psoriatic arthritis in adult patients. The marketing authorisation was granted to Celltrion Healthcare Hungary Kft. under the biosimilar expedited pathway.
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EMA — authorised 14 August 2025
- Application: EMEA/H/C/006467
- Marketing authorisation holder: Gedeon Richter Plc.
- Local brand name: Usymro
- Indication: Plaque psoriasis Usymro 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 psoriasis Usymro is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Usym
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for Usymro (IL-23 Therapy) on 14 August 2025. Usymro is indicated 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 adults. Additionally, Usymro is approved for the treatment of moderately to severely active Crohn's disease in adults and children weighing at least 40 kg. The marketing authorisation holder is Gedeon Richter Plc, and Usymro is a biosimilar product.
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EMA — authorised 17 September 2025
- Application: EMEA/H/C/006794
- Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
- Local brand name: Usrenty
- Indication: Plaque psoriasis Usrenty 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 psoriasis Usrenty is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Usr
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for Usrenty (IL-23 Therapy) on 17 September 2025. Usrenty is indicated for the treatment of moderate to severe plaque psoriasis in adults and children aged 6 years and older who have failed to respond to or are intolerant to other systemic therapies. It is also indicated for the treatment of active psoriatic arthritis in adults and moderately to severely active Crohn's disease in adults who have had an inadequate response to conventional therapy or a TNFα antagonist.
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EMA — authorised 17 November 2025
- Application: EMEA/H/C/006667
- Marketing authorisation holder: Stada Arzneimittel AG
- Local brand name: Usgena
- Indication: Crohn’s Disease Usgena 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. Ulcerative colitis Usgena is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasis Usgena is indicated for the treatment of moderate to severe plaque ps
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) approved Usgena (IL-23 Therapy) for the treatment of adult patients with moderately to severely active Crohn's disease, ulcerative colitis, and plaque psoriasis. Usgena is also indicated for the treatment of psoriatic arthritis in adult patients. The approval was granted on 17 November 2025, and the marketing authorisation holder is Stada Arzneimittel AG.
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EMA
- Application: EMEA/H/C/006415
- Marketing authorisation holder: Amgen Technology (Ireland) UC
- Local brand name: Upstelda
- Indication: Treatment of moderate to severe plaque psoriasis in adults, children and adolescents, active psoriatic arthritis in adults and Crohn’s Disease.
- Status: withdrawn
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