Imuldosa (ustekinumab)
- Region
- 🇪🇺 EU
- Active substance
- ustekinumab
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Crohn Disease; Psoriasis; Arthritis, Psoriatic
- CHMP opinion
- Thu 17 Oct 2024
- EU approval
- Thu 12 Dec 2024
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006221
- ATC
- L04AC05
- Official record
- www.ema.europa.eu
Indication
Adult Crohn’s Disease Imuldosa 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. Paediatric Crohn’s Disease Imuldosa is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Ulcerative colitis Imuldosa 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 Imuldosa 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 Imuldosa 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) Imuldosa, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease- modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Wezenla Authorised · Amgen Technology (Ireland) UC
- 🇪🇺 Otulfi Authorised · Fresenius Kabi Deutschland GmbH
- 🇪🇺 Pyzchiva Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Stelara Authorised · Janssen-Cilag International NV
- 🇪🇺 Fymskina Authorised · Formycon AG
- 🇪🇺 Steqeyma Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Usymro Authorised · Gedeon Richter Plc.
- 🇪🇺 Uzpruvo Authorised · Stada Arzneimittel AG
- 🇪🇺 Usrenty Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Usgena Authorised · Stada Arzneimittel AG
- 🇪🇺 Yesintek Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Qoyvolma Withdrawn · Celltrion Healthcare Hungary Kft.
Follow Imuldosa
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.