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Rituximab Biosimilar
Rituximab Biosimilar is a Monoclonal antibody Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Non-Hodgkin's lymphoma, Chronic lymphocytic leukemia. Also known as: TRUXIMA®, HLX01, RUXIENCE®, RIABNI®.
Rituximab Biosimilar works by targeting and depleting CD20-positive B cells.
Rituximab Biosimilar is a binding agent that targets the B-lymphocyte antigen CD20. It is used to treat various conditions, including CD19 Positive, Mantle Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma, and Refractory B-Cell Non-Hodgkin Lymphoma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 Biosimilar |
|---|---|
| Also known as | TRUXIMA®, HLX01, RUXIENCE®, RIABNI® |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Monoclonal antibody |
| Target | CD20 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
It binds to the CD20 antigen on the surface of B cells, leading to their destruction through mechanisms such as complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity. This results in a reduction in B cell count and subsequent decrease in disease activity.
Approved indications
- Non-Hodgkin's lymphoma
- Chronic lymphocytic leukemia
Common side effects
- Infusion-related reactions
- Infections
- Neutropenia
- Thrombocytopenia
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 Biosimilar CI brief — competitive landscape report
- Rituximab Biosimilar updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Rituximab Biosimilar
What is Rituximab Biosimilar?
How does Rituximab Biosimilar work?
What is Rituximab Biosimilar used for?
Who makes Rituximab Biosimilar?
Is Rituximab Biosimilar also known as anything else?
What drug class is Rituximab Biosimilar in?
What development phase is Rituximab Biosimilar in?
What are the side effects of Rituximab Biosimilar?
What does Rituximab Biosimilar target?
Related
- Drug class: All Monoclonal antibody drugs
- Target: All drugs targeting CD20
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-Hodgkin's lymphoma
- Indication: Drugs for Chronic lymphocytic leukemia
- Also known as: TRUXIMA®, HLX01, RUXIENCE®, RIABNI®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing