Rituxan (rituximab) is a CD20-directed cytolytic monoclonal antibody used in hematologic malignancies and selected autoimmune conditions. Labeling lists indications including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (with methotrexate), and granulomatosis with polyangiitis/microscopic polyangiitis (with glucocorticoids). U.S. initial approval was in 1997.
The Middle East and Africa biosimilars market is estimated to grow from USD 1.15 billion to USD 5.73 billion by 2035 at a 19% CAGR. Monoclonal antibodies hold almost 55% of market share, while oncological disorders dominate demand.
Zenyaku Kogyo obtained Japanese regulatory approval for Rituxan (rituximab) as a treatment for autoimmune hemolytic anemia, a government-designated intractable disease. The approval follows a public knowledge-based application submitted in August 2025.
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
Dr Reddy's and Biocon plan to launch generic versions of Novo Nordisk's weight-loss drugs at up to 60% below branded prices as semaglutide patents expire, targeting a global market projected to reach $150 billion by the early 2030s.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06790420 |
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study |
COMPLETED | |
| NCT04323748 |
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura |
RECRUITING | PHASE1 |
| NCT03531736 |
T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT02819726 |
PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis |
COMPLETED | PHASE1 |
| NCT02296775 |
Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis |
COMPLETED | PHASE1/PHASE2 |
| NCT02282514 |
Stem Cell Transplantation for Stiff Person Syndrome (SPS) |
TERMINATED | PHASE1/PHASE2 |
| NCT02260804 |
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma |
COMPLETED | PHASE3 |
| NCT02240407 |
Re-administration of Intramuscular AAV9 in Patients With Late-Onset Pompe Disease |
COMPLETED | PHASE1 |
| NCT02162771 |
To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan |
COMPLETED | PHASE3 |
| NCT02149121 |
PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis |
COMPLETED | PHASE3 |
