Infliximab

Infliximab was first approved by the U.S. Food and Drug Administration (FDA) on August 24, 1998, then approved by European Medicine Agency (EMA) on August 13, 1999, Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on January 17, 2002, China Food and Drug Administration (CFDA) on May 17, 2006. It was initially developed by Janssen (a member of Johnson & Johnson), then co-marketed as Remicade® by Janssen, Merck & Co and Mitsubishi Tanabe.

Infliximab is a tumor necrosis factor (TNF) blocker, which binds with high affinity to the soluble and transmembrane forms of TNFα and inhibits binding of TNFα with its receptors. It is indicated for the treatment of patients with Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and Behcet's disease. 

Remicade® is available as injection (lyophilized powder) for intravenous infusion, containing 100 mg of Infliximab in a 20 mL vial. In Crohn's disease, ulcerative colitis, psoriatic arthritis , plaque psoriasis and Behcet's disease, the recommended dose is 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. In rheumatoid arthritis, the recommended dose is 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. In ankylosing spondylitis, the recommended dose is 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.

General Information

Update Date:2016-02-29

Drug Name:
Infliximab
Research Code:
TA-650
Trade Name:
Remicade® / 类克®
MOA:
Tumor necrosis factor blocker
Indication:
Crohn's disease; Ulcerative colitis; Rheumatoid arthritis; Ankylosing Spondylitis (AS); Psoriatic arthritis; Behcet's disease; Pediatric Crohn’s disease; Pediatric ulcerative colitis
Status:
Approved
Company:
Janssen (Originator), Johnson & Johnson (Originator) , Merck Sharp & Dohme,Mitsubishi Tanabe
Sales:
$8948.6 Million (Y2015);
$9900.1 Million (Y2014);;
$9769.8 Million (Y2013);;
$9117.6 Million (Y2012);;
$8947.5 Million (Y2011);
ATC Code:
L04AB02
Approved Countries or Area

Update Date:2015-09-01

Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
1998-08-24 Marketing approval Remicade Crohn's disease, Ulcerative colitis, Rheumatoid arthritis, Psoriatic arthritis Injection, Lyophilized powder, For solution 100 mg Janssen Orphan/Priority
Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
1999-08-13 Marketing approval Remicade Crohn's disease, Rheumatoid arthritis, Psoriatic arthritis Injection, Powder, For solution 100 mg Janssen
Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2002-01-17 Marketing approval Remicade Crohn's disease, Rheumatoid arthritis, Psoriatic arthritis Injection, Lyophilized powder, For solution 100 mg Janssen, Mitsubishi Tanabe Orphan
Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2006-05-17 Marketing approval Remicade/类克 Crohn's disease, Psoriatic arthritis Injection, Powder, For solution 100 mg Janssen
Biology Structure

Update Date:2015-07-29

Type Whole antibody
Source Chimeric
Molecular Formula C6462H9996N1728O2038S44
Molecular Weight 149100
CAS No. 170277-31-3
Expression System Mammalian Cell