SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| BIMZELX | 160 mg/ml | Solution for injection in pre-filled pen · Subcutaneous use | 2 Pre-filled pen | SAR 8873.50 | Biological · Prescription | UCB Pharma S.A. | Valid |
Indications — CHI Daman Drug Formulary
PSORIASIS; PSORIATIC ARTHRITIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| BIMZELX | 160ML | injectable · injection | UCB INC | Prescription | 17 Oct 2023 |
EMA European Union — centrally authorised medicines
Bimzelx UCB Pharma S.A. · Authorised · authorised 20 Aug 2021 · ATC L04AC
Therapeutic indication (EMA)
Plaque psoriasis Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Hidradenitis suppurativa (HS)Bimzelx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| BIMZELX | 02525267 | 160 MG / ML | SOLUTION · SUBCUTANEOUS | UCB CANADA INC |
| BIMZELX | 02525275 | 160 MG / ML | SOLUTION · SUBCUTANEOUS | UCB CANADA INC |
| BIMZELX | 02553619 | 320 MG / 2 ML | SOLUTION · SUBCUTANEOUS | UCB CANADA INC |
| BIMZELX | 02553627 | 320 MG / 2 ML | SOLUTION · SUBCUTANEOUS | UCB CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | BIMZELX 160 MG/ML AUTOINJECTOR | $8035.07333 | per ML | 23 Sep 2026 |
| US NADAC | BIMZELX 160 MG/ML AUTOINJECTOR | $8112.5853 | per ML | 1 Jan 2026 |
| US NADAC | BIMZELX 320 MG/2 ML AUTOINJECT | $8016.03643 | per ML | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.