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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

FDA Approved Products

HADLIMA
Manufacturer:A-S Medication Solutions
Route:SUBCUTANEOUS
Strength:40 mg in 0.4 mL
Approved: 2022/11/25
NDC:50090-6704
AMJEVITA
Manufacturer:Amgen Inc
Route:SUBCUTANEOUS
Strength:80 mg in 0.8 mL
Approved: 2023/08/18
NDC:55513-481
AMJEVITA
Manufacturer:Amgen Inc
Route:SUBCUTANEOUS
Strength:80 mg in 0.8 mL
Approved: 2023/08/18
NDC:55513-480
Yuflyma
Manufacturer:CELLTRION USA, Inc.
Route:SUBCUTANEOUS
Strength:20 mg in 0.2 mL
Approved: 2023/12/01
NDC:72606-024
ABRILADA
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:SUBCUTANEOUS
Strength:40 mg in 0.8 mL
Approved: 2024/01/17
NDC:0069-0319

Singapore Approved Products

AMGEVITA SOLUTION FOR INJECTION IN PREFILLED SYRINGE 40 mg/0.8 ml
Manufacturer:Amgen Manufacturing Limited
Form:INJECTION, SOLUTION
Strength:40 mg/0.8 ml
Online:Yes
Approved: 2019/07/02
Approval:SIN15731P
ABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED SYRINGE 20 MG/0.4 ML
Manufacturer:Catalent Indiana, LLC
Form:INJECTION, SOLUTION
Strength:20mg/0.4ml
Online:Yes
Approved: 2022/08/02
Approval:SIN16561P
HUMIRA SOLUTION FOR INJECTION 40MG/0.8ML (PRE-FILLED SYRINGE)
Manufacturer:VETTER PHARMA-FERTIGUNG GMBH & CO KG (Ravensburg)
Form:INJECTION
Strength:40mg/0.8ml
Online:Yes
Approved: 2019/08/26
Approval:SIN15787P
IDACIO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.8ML
Manufacturer:Merck Serono S.p.A. (Bari)
Form:INJECTION, SOLUTION
Strength:40mg/0.8ml
Online:Yes
Approved: 2021/01/25
Approval:SIN16084P
HUMIRA SOLUTION FOR INJECTION 80MG/0.8ML (PREFILLED SYRINGE)
Manufacturer:Vetter Pharma-Fertigung GmbH & Co. KG (Schützenstrasse), AbbVie Biotechnology Ltd (ABL)
Form:INJECTION, SOLUTION
Strength:80.0mg/0.8mL
Online:Yes
Approved: 2020/03/19
Approval:SIN15915P

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