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Adalimumab

Generic Name
Adalimumab
Brand Names
Amjevita, Cyltezo, Humira, Hyrimoz, Yusimry, Hulio, Hefiya, Libmyris, Imraldi, Amsparity, Idacio, Hukyndra, Amgevita, Yuflyma
Drug Type
Biotech
CAS Number
331731-18-1
Unique Ingredient Identifier
FYS6T7F842

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
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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No FDA approvals found for this drug.

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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