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Rituximab Pfizer (rituximab-pfizer)
Rituximab Pfizer (generic name: rituximab-pfizer) is a For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance ther Monoclonal antibody drug developed by Pfizer Inc.. It is currently in preclinical development.
For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance ther
Rituximab Pfizer, also known as PF-05280586, is a binding agent that targets the B-lymphocyte antigen CD20. It is used to treat conditions such as Rheumatoid Arthritis, Follicular Lymphoma, and Lymphoma.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. 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 | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +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-pfizer |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance ther |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
Rituximab Pfizer works by targeting a specific protein called CD20 that appears on the surface of B cells—a type of white blood cell involved in producing antibodies and fighting infection. By binding to this CD20 protein, rituximab acts like a label or flag, essentially marking these B cells for destruction. The immune system then recognizes these marked cells and eliminates them through several mechanisms, including direct killing and antibody-dependent cell killing. In cancer, this approach is beneficial because B-cell lymphomas and leukemias represent abnormal, dangerous versions of B cells that multiply uncontrollably. By removing these malignant cells, rituximab helps shrink tumors and improve survival. In autoimmune diseases like rheumatoid arthritis, the benefit comes from reducing autoreactive B cells that are mistakenly attacking the body's own tissues, which decreases inflammation and joint damage. Rituximab Pfizer is a biosimilar, meaning it's manufactured through a different biological process than the original rituximab but is designed to work identically. This provides patients with the same therapeutic benefits while offering potential cost advantages. The drug is administered intravenously and works gradually over weeks, with effects that can last for months after treatment completion.
Approved indications
Pipeline indications
- Lymphoma — preclinical
Common side effects
Key clinical trials
- National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life (N/A)
- Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin' (Phase 2)
- Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who (N/A)
- A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab (Phase 1)
- A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymph (Phase 3)
- Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Ch (Phase 3)
- Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Cont (Phase 2)
- A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment O (Phase 3)
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 Pfizer CI brief — competitive landscape report
- Rituximab Pfizer updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Rituximab Pfizer
What is Rituximab Pfizer?
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Related
- Drug class: All For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance ther drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing