Overview
Adalimumab is a subcutaneously administered biological disease modifier for the treatment of rheumatoid arthritis and other chronic debilitating diseases mediated by tumor necrosis factor. It was originally launched by Abbvie in the U.S. and approved in 2002 by the FDA. This drug is frequently known as Humira. It is produced by recombinant DNA technology using a mammalian cell expression system. This drug is available in a prefilled syringe form and convenient pen form for subcutaneous self-administered doses. Several biosimilars to adalimumab. Adalimumab-atto was the first adalimumab biosimilar approved by the FDA in 2016. Adalimumab-adaz was approved by the FDA on October 31, 2018. Other biosimilars include adalimumab-fkjp, which was approved in July 2022, and adalimumab-bwwd, which was approved in August 2022. A biosimilar marketed as Hyrimoz, a high-concentration formulation of adalimumab, is also available.
Indication
Adalimumab is indicated for the following conditions: Adalimumab has also been used off-label to treat Pyoderma gangrenosum.
Associated Conditions
- Ankylosing Spondylitis (AS)
- Hidradenitis Suppurativa (HS)
- Moderate to Severe Chronic Plaque Psoriasis
- Moderate to Severe Rheumatoid Arthritis
- Moderately to Severely Active Crohn's Disease
- Moderately to Severely Active Ulcerative Colitis
- Non-infectious Intermediate, Posterior and Panuveitis
- Polyarticular Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Pyoderma Gangrenosum
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/11 | Not Applicable | Not yet recruiting | City of Hope Medical Center | ||
2025/06/10 | Phase 4 | Not yet recruiting | Chinese SLE Treatment And Research Group | ||
2025/05/30 | Phase 2 | Not yet recruiting | |||
2025/04/23 | Phase 2 | Not yet recruiting | |||
2025/04/13 | Phase 1 | Not yet recruiting | |||
2025/02/27 | Phase 2 | Recruiting | |||
2025/02/18 | Phase 4 | Not yet recruiting | The Affiliated Hospital Of Guizhou Medical University | ||
2024/12/11 | Not Applicable | Recruiting | |||
2024/10/15 | Phase 3 | Active, not recruiting | |||
2024/09/19 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| CELLTRION USA, Inc. | 72606-040 | SUBCUTANEOUS | 80 mg in 0.8 mL | 12/8/2023 | |
| Cordavis Limited | 83457-100 | SUBCUTANEOUS | 40 mg in 0.4 mL | 6/15/2023 | |
| Cordavis Limited | 83457-108 | SUBCUTANEOUS | 20 mg in 0.2 mL | 6/15/2023 | |
| Cordavis Limited | 83457-101 | SUBCUTANEOUS | 40 mg in 0.4 mL | 6/15/2023 | |
| Amgen Inc | 55513-480 | SUBCUTANEOUS | 80 mg in 0.8 mL | 8/18/2023 | |
| Amgen Inc | 55513-399 | SUBCUTANEOUS | 20 mg in 0.2 mL | 8/18/2023 | |
| Sandoz Inc | 61314-391 | SUBCUTANEOUS | 10 mg in 0.1 mL | 11/21/2024 | |
| Sandoz Inc. | 61314-391 | SUBCUTANEOUS | 10 mg in 0.1 mL | 11/21/2024 | |
| Coherus BioSciences Inc | 70114-210 | SUBCUTANEOUS | 40 mg in 0.8 mL | 2/28/2023 | |
| Amgen Inc | 55513-413 | SUBCUTANEOUS | 10 mg in 0.2 mL | 8/18/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/26/2018 | ||
Authorised | 9/17/2018 | ||
Authorised | 2/11/2021 | ||
Authorised | 7/26/2018 | ||
Authorised | 8/24/2017 | ||
Authorised | 11/15/2021 | ||
Authorised | 2/13/2020 | ||
Authorised | 3/21/2017 | ||
Authorised | 9/8/2003 | ||
Authorised | 4/2/2019 |
HSA Drug Approvals
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Adalimumab Solution for Injection | 国药准字S20190043 | 生物制品 | 注射剂 | 12/6/2019 | |
| Adalimumab Solution for Injection | 国药准字SJ20200007 | 生物制品 | 注射剂 | 1/7/2025 | |
| Adalimumab Solution for Injection | S20191006 | 生物制品 | 注射剂 | 11/15/2019 | |
| Adalimumab Solution for Injection | 国药准字SJ20181019 | 生物制品 | 注射剂 | 11/4/2021 | |
| Adalimumab Solution for Injection | 国药准字S20217001 | 生物制品 | 注射剂 | 3/11/2021 | |
| Adalimumab Solution for Injection | 国药准字SJ20215002 | 生物制品 | 注射剂 | 3/15/2021 | |
| Adalimumab Solution for Injection | 国药准字SJ20191006 | 生物制品 | 注射剂 | 9/2/2024 | |
| Adalimumab Solution for Injection | 国药准字S20220008 | 生物制品 | 注射剂 | 3/1/2022 | |
| Adalimumab Solution for Injection | 国药准字S20220001 | 生物制品 | 注射剂 | 1/18/2022 | |
| Adalimumab Solution for Injection | 国药准字S20230034 | 生物制品 | 注射剂 | 6/7/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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