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.
Update Date:2016-02-29
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 |
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 |