Overview
Rituximab is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light and heavy-chain variable region sequences and human constant region sequences , . It was originally approved by the U.S. FDA in 1997 as a single agent to treat patients with B-cell Non-Hodgkin's Lymphoma (NHL) , however, has now been approved for a variety of conditions . On November 28, 2018, the US FDA approved Truxima, the first biosimilar to Rituxan (Rituximab) .
Indication
Rituximab is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s Lymphoma (NHL) as a single agent. Also, it is indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Additionally, rituximab is indicated for the treatment of adult patients with non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; and previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. Rituximab, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL). In combination with methotrexate, rituximab is indicated for the treatment of adult patients with moderately-to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. Additionally, rituximab, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). RITUXAN (rituximab injection for intravenous use) is indicated for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy; as well as the treatment of adult patients with moderate to severe pemphigus vulgaris. These indications for RITUXAN are not included in the labels of rituximab biosimilar products (rituximab-arrx, rituximab-abbs, rituximab-pvvr). The combination product RITUXAN HYCELA (rituximab and hyaluronidase human injection, for subcutaneous use) is not indicated for the treatment of non-malignant conditions.
Associated Conditions
- Active, Moderate to Severe Rheumatoid Arthritis
- Chronic Lymphocytic Leukemia
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Follicular Non-Hodgkin's Lymphoma
- Granulomatosis With Polyangiitis
- Microscopic Polyangiitis (MPA)
- Advanced Burkitt Lymphoma (BL)
- Advanced Burkitt-like lymphoma
- Advanced Diffuse Large B-Cell Lymphoma (DLBCL)
- Advanced Mature B-cell type acute leukaemia
- Moderate Pemphigus Vulgaris (PV)
- Non-progressive Low Grade Non-Hodgkin's Lymphoma (NHL)
- Refractory Low Grade Non-Hodgkin's Lymphoma (NHL)
- Refractory follicular B-cell non-Hodgkin's lymphoma
- Relapsed Low Grade Non-Hodgkin's Lymphoma (NHL)
- Relapsed follicular B-cell non-Hodgkin's lymphoma
- Severe Pemphigus Vulgaris (PV)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/04 | Not Applicable | Not yet recruiting | Ostfold Hospital Trust | ||
2025/07/03 | Not Applicable | Completed | Wuhan Children's Hospital | ||
2025/06/27 | Not Applicable | Recruiting | Pirogov Russian National Research Medical University | ||
2025/06/25 | Phase 2 | Completed | Shereen Medhat Mohammed Elsayed Nassar | ||
2025/06/24 | Phase 2 | Not yet recruiting | |||
2025/06/19 | Phase 2 | Not yet recruiting | Shanghai JMT-Bio Inc. | ||
2025/06/11 | Phase 2 | Not yet recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | ||
2025/06/08 | Phase 4 | Not yet recruiting | |||
2025/05/23 | Phase 1 | Not yet recruiting | |||
2025/05/21 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cephalon, Inc. | 63459-104 | INTRAVENOUS | 10 mg in 1 mL | 11/2/2022 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0238 | INTRAVENOUS | 100 mg in 10 mL | 10/30/2023 | |
| Amgen Inc | 55513-224 | INTRAVENOUS | 100 mg in 10 mL | 6/16/2025 | |
| Cephalon, Inc. | 63459-103 | INTRAVENOUS | 10 mg in 1 mL | 11/2/2022 | |
| Genentech, Inc. | 50242-109 | SUBCUTANEOUS | 120 mg in 1 mL | 11/16/2022 | |
| Genentech, Inc. | 50242-051 | INTRAVENOUS | 10 mg in 1 mL | 6/6/2023 | |
| Genentech, Inc. | 50242-053 | INTRAVENOUS | 10 mg in 1 mL | 6/6/2023 | |
| Genentech, Inc. | 50242-108 | SUBCUTANEOUS | 120 mg in 1 mL | 11/16/2022 | |
| Amgen Inc | 55513-326 | INTRAVENOUS | 500 mg in 50 mL | 6/16/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0249 | INTRAVENOUS | 500 mg in 50 mL | 10/30/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/17/2017 | ||
Authorised | 6/15/2017 | ||
Authorised | 6/2/1998 | ||
Authorised | 7/13/2017 | ||
Authorised | 9/19/2024 | ||
Authorised | 4/1/2020 | ||
Authorised | 6/15/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Mabthera Concentrate for Solution for Infusion 100mg/10ml | SIN13718P | INFUSION, SOLUTION CONCENTRATE | 10mg/ml | 10/30/2009 | |
| RUXIENCE CONCENTRATE FOR SOLUTION FOR INFUSION 500mg/50mL | SIN16452P | INFUSION, SOLUTION CONCENTRATE | 500mg/50ml | 3/25/2022 | |
| TRUXIMA® CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML | SIN15671P | INFUSION, SOLUTION CONCENTRATE | 10mg/mL | 4/24/2019 | |
| MABTHERA SOLUTION FOR SUBCUTANEOUS INJECTION 1400MG | SIN15023P | INJECTION, SOLUTION | 1400mg | 6/1/2016 | |
| RUXIENCE CONCENTRATE FOR SOLUTION FOR INFUSION 100mg/10mL | SIN16451P | INFUSION, SOLUTION CONCENTRATE | 100mg/10ml | 3/25/2022 | |
| RIXATHON CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML | SIN15970P | INFUSION, SOLUTION CONCENTRATE | 100mg/10ml | 6/30/2020 | |
| MABTHERA CONCENTRATE FOR SOLUTION FOR INFUSION 500 mg/50ml | SIN09946P | INJECTION | 10 mg/ml | 8/22/1998 | |
| RIXATHON CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/50ML | SIN15969P | INFUSION, SOLUTION CONCENTRATE | 500mg/50ml | 6/30/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rituximab Injection | 国药准字S20201002 | 生物制品 | 注射剂 | 4/15/2020 | |
| Rituximab Injection | 国药准字SJ20160029 | 生物制品 | 注射剂 | 3/26/2021 | |
| Rituximab Injection | 国药准字SJ20160031 | 生物制品 | 注射剂 | 3/26/2021 | |
| Rituximab Injection | 国药准字S20190021 | 生物制品 | 注射剂 | 12/18/2023 | |
| Rituximab Injection | 国药准字S20240008 | 生物制品 | 注射剂 | 3/19/2024 | |
| Rituximab Injection | 国药准字SJ20160030 | 生物制品 | 注射剂 | 3/26/2021 | |
| Rituximab Injection | 国药准字S20230033 | 生物制品 | 注射剂 | 5/26/2023 | |
| Rituximab Injection | 国药准字S20200022 | 生物制品 | 注射剂 | 9/30/2020 | |
| Rituximab Injection | 国药准字SJ20170002 | 生物制品 | 注射剂 | 3/26/2021 | |
| MabThera sc | 国药准字SJ20240013 | 生物制品 | 注射剂 | 4/2/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| MABTHERA CONC FOR SOL FOR INF 100MG/10ML | N/A | N/A | N/A | 2/8/2010 | |
| MABTHERA SOLUTION FOR SUBCUTANEOUS INJECTION 1400MG | N/A | N/A | N/A | 9/15/2016 | |
| MABTHERA INJ 100MG/10ML | N/A | N/A | N/A | 5/12/2000 | |
| MABTHERA INJ 500MG/50ML | N/A | N/A | N/A | 5/12/2000 | |
| MABTHERA CONC FOR SOL FOR INF 500MG/50ML | N/A | N/A | N/A | 2/8/2010 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TRUXIMA rituximab (rch) 100 mg/ 10 mL concentrate solution for intravenous infusion | 285816 | Medicine | A | 4/16/2018 | |
| TRUXIMA rituximab (rch) 500 mg/ 50 mL concentrate solution for intravenous infusion | 285815 | Medicine | A | 4/16/2018 | |
| RIXIMYO rituximab (rch) 500mg/50mL concentrated injection vial | 281781 | Medicine | A | 11/30/2017 | |
| RIXIMYO rituximab (rch) 100mg/10mL concentrated injection vial | 281782 | Medicine | A | 11/30/2017 | |
| RUXIENCE Rituximab 100mg/ 10mL concentrated solution for injection vial | 330537 | Medicine | A | 3/3/2021 | |
| RUXIENCE Rituximab 500mg/ 50mL concentrated solution for injection vial | 330536 | Medicine | A | 3/3/2021 |
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