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Rituximab or biosimilar
Rituximab or biosimilar is a Anti-CD20 monoclonal antibody Small molecule drug developed by Sanofi. It is currently in Phase 2 development. Also known as: Riabni, Rituxan, Ruxience, Truxima.
Rituximab binds to CD20 protein on B-cells, triggering immune-mediated cell destruction and depletion of B-lymphocytes.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Rituximab or biosimilar |
|---|---|
| Also known as | Riabni, Rituxan, Ruxience, Truxima |
| Sponsor | Sanofi |
| Drug class | Anti-CD20 monoclonal antibody |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
Rituximab is a chimeric monoclonal antibody that specifically targets the CD20 antigen expressed on the surface of B-lymphocytes. Upon binding, it induces B-cell lysis through complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and direct apoptosis, leading to depletion of both normal and malignant B-cells.
Approved indications
Common side effects
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia (PHASE1, PHASE2)
- Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial (PHASE2)
- Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (PHASE2)
- Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (PHASE3)
- Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma (PHASE1)
- Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery (PHASE1)
- Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rituximab or biosimilar CI brief — competitive landscape report
- Rituximab or biosimilar updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Rituximab or biosimilar
What is Rituximab or biosimilar?
How does Rituximab or biosimilar work?
Who makes Rituximab or biosimilar?
Is Rituximab or biosimilar also known as anything else?
What drug class is Rituximab or biosimilar in?
What development phase is Rituximab or biosimilar in?
Related
- Drug class: All Anti-CD20 monoclonal antibody drugs
- Manufacturer: Sanofi — full pipeline
- Also known as: Riabni, Rituxan, Ruxience, Truxima
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing