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.
Background
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
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2007/01/12 | Phase 1 | Completed | |||
2006/07/04 | Phase 2 | UNKNOWN | |||
2006/06/20 | Phase 3 | Completed | |||
2006/04/05 | Phase 2 | Terminated | |||
2006/03/22 | Phase 3 | Completed | |||
2006/03/02 | Phase 2 | Terminated | |||
2006/02/27 | Phase 2 | Completed | |||
2006/02/15 | Phase 4 | UNKNOWN | Goupe d'Etudes et de Recherche Clinique En Rhumatologie | ||
2006/01/10 | Phase 2 | Completed | Pariser, Robert J., M.D. | ||
2005/10/13 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |