SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| ENBREL 50MG PRE-FILLED PEN | 50 mg | Solution for injection · Subcutaneous use | 4 Pre-filled syringe | SAR 3031.60 | Biological · Prescription | PFIZER SAUDI LIMITED | Valid |
| Erelzi | 50 mg | Solution for injection in pre-filled pen · Subcutaneous use | 4 Pre-filled pen | SAR 1742.45 | Biological · Prescription | SANDOZ GMBH | Valid |
| Erelzi | 50 mg | concentrate for solution for injection · Subcutaneous use | 4 Pre-filled syringe | SAR 1742.45 | Biological · Prescription | Sandoz GmbH | Valid |
| Erelzi | 25 mg | Solution for injection in pre-filled syringe · Subcutaneous use | 4 Pre-filled syringe | SAR 871.40 | Biological · Prescription | SANDOZ GMBH | Valid |
| Nepexto | 50 mg | Solution for injection in pre-filled pen · Subcutaneous use | 4 Pre-filled pen | SAR 2738.30 | Biological · Prescription | Boston Oncology Arabia | Valid |
| Nepexto | 50 mg | Solution for injection in pre-filled syringe · Subcutaneous use | 4 Pre-filled syringe | SAR 2738.30 | Biological · Prescription | Boston Oncology Arabia | Valid |
| Nepexto | 25 mg | Solution for injection in pre-filled syringe · Subcutaneous use | 4 Pre-filled syringe | SAR 1354.15 | Biological · Prescription | Boston Oncology Arabia | Valid |
| ENBREL 50MG PRE-FILLED SYRINGE | 50 mg | Solution for injection · Intravenous use | 4 Pre-filled syringe | SAR 5372.30 | Biological · Prescription | WYETH | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ACTIVE ENTHESITIS JUVENILE ARTHRITIS; ANKYLOSING SPONDYLITIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; JUVENILE ACTIVE SACROILITIS; JUVENILE POLYARTHRITIS; PSORIASIS; PSORIATIC ARTHRITIS; RHEUMATOID ARITHRITIS; SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| ENBREL | 25MG/VIAL | vial · subcutaneous | IMMUNEX | Prescription | 2 Nov 1998 |
| ENBREL | 50MG/ML | syringe | IMMUNEX | Prescription | 2 Nov 1998 |
| ERELZI | 25MG/0.5ML; 50MG/ML | injectable · injection | SANDOZ | Prescription | 30 Aug 2016 |
| ETICOVO | 25MG/0.5ML; 50MG/1ML | injectable · injection | SAMSUNG BIOEPIS CO LTD | Prescription | 25 Apr 2019 |
EMA European Union — centrally authorised medicines
Enbrel Pfizer Europe MA EEIG · Authorised · authorised 2 Feb 2000 · ATC L04AB01
Therapeutic indication (EMA)
Rheumatoid arthritis Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid-factor-positive or -negative) and extended oligoarthritis in children and adolescents from the age of two years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Enbrel has not been studied in children aged less than two years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of six years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Benepali Samsung Bioepis NL B.V. · Authorised · authorised 13 Jan 2016 · ATC L04AB01
Therapeutic indication (EMA)
Rheumatoid arthritis Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Benepali, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Erelzi Sandoz GmbH · Authorised · authorised 23 Jun 2017 · ATC L04AB01
Therapeutic indication (EMA)
Rheumatoid arthritis Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease?modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X?ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis?related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease?modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X?ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non?radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C?reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non?steroidal anti?inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet?A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Nepexto Biosimilar Collaborations Ireland Limited · Authorised · authorised 20 May 2020 · ATC L04AB01
Therapeutic indication (EMA)
Rheumatoid arthritis Nepexto in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Nepexto can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Nepexto is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Nepexto, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Fubelv Biosimilar Collaborations Ireland Limited · Authorised · authorised 23 Apr 2026 · ATC L04AB01
Therapeutic indication (EMA)
Rheumatoid arthritisFubelv in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.Fubelv can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Fubelv is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.Fubelv, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.Juvenile idiopathic arthritisTreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease- modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritisAnkylosing spondylitisTreatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).Plaque psoriasisTreatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).Paediatric plaque psoriasisTreatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Lifmior Pfizer Europe MA EEIG · Lapsed · authorised 13 Feb 2017 · ATC L04AB01
Therapeutic indication (EMA)
Rheumatoid arthritis; Juvenile idiopathic arthritis Psoriatic arthritis; Axial spondyloarthritis; Plaque psoriasis; Paediatric plaque psoriasis.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| BRENZYS | 02455323 | 50 MG / ML | SOLUTION · SUBCUTANEOUS | SAMSUNG BIOEPIS CO., LTD |
| BRENZYS | 02455331 | 50 MG / ML | SOLUTION · SUBCUTANEOUS | SAMSUNG BIOEPIS CO., LTD |
| ENBREL | 02274728 | 50 MG / ML | SOLUTION · SUBCUTANEOUS | IMMUNEX CORPORATION |
| ERELZI | 02462850 | 50 MG / ML | SOLUTION · SUBCUTANEOUS | SANDOZ CANADA INCORPORATED |
| ERELZI | 02462869 | 50 MG / ML | SOLUTION · SUBCUTANEOUS | SANDOZ CANADA INCORPORATED |
| ERELZI | 02462877 | 25 MG / 0.5 ML | SOLUTION · SUBCUTANEOUS | SANDOZ CANADA INCORPORATED |
| RYMTI | 02530295 | 50 MG / 1 ML | SOLUTION · SUBCUTANEOUS | LUPIN PHARMA CANADA LIMITED |
| RYMTI | 02530309 | 50 MG / 1 ML | SOLUTION · SUBCUTANEOUS | LUPIN PHARMA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | ENBREL 25 MG/0.5 ML SYRINGE | $2084.14429 | per ML | 23 Sep 2026 |
| US NADAC | ENBREL 50 MG/ML MINI CARTRIDGE | $2080.995 | per ML | 23 Sep 2026 |
| US NADAC | ENBREL 50 MG/ML SURECLICK | $2083.47839 | per ML | 23 Sep 2026 |
| US NADAC | ENBREL 50 MG/ML SYRINGE | $2080.59222 | 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.
WHO WHO Model List of Essential Medicines (2025)
- 8.1. Immunomodulators for non-malignant disease · complementary
Therapeutic equivalent to adalimumab for Axial spondyloarthritis; Therapeutic equivalent to adalimumab for Crohn disease site; Therapeutic equivalent to adalimumab for Rheumatoid arthritis - 29.3. Medicines for juvenile joint diseases · complementary
Therapeutic equivalent to adalimumab for Juvenile idiopathic arthritis - 13.4. Dermatological medicines > Medicines affecting skin differentiation and proliferation · complementary
Therapeutic equivalent to adalimumab for Psoriasis of unspecified type
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.