Rituximab (rituximab)
Rituximab is a cd20-directed cytolytic monoclonal antibody; chimeric murine/human igg1 kappa antibody (biologic, not a small-molecule generic) from Genentech, Inc. (a member of the Roche Group), with Biogen; Rituxan is jointly marketed by Biogen and Genentech USA in the US; MabThera is marketed by Roche, marketed originally as Rituxan. This monograph covers approved indications, mechanism, dosing, side effects, the generic manufacturer landscape and verified list prices.
Overview
Rituximab is a chimeric murine/human IgG1 kappa monoclonal antibody that binds the CD20 antigen on pre-B and mature B lymphocytes and destroys those cells through complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. Because CD20 is carried by both malignant B cells and the B cells that drive autoimmunity, rituximab treats blood cancers and autoimmune diseases alike. It is sold by Roche/Genentech with Biogen as Rituxan in the US and MabThera in Europe and most other markets (Chinese brand name 美罗华).
Approved uses include relapsed or refractory low-grade or follicular CD20-positive non-Hodgkin lymphoma; first-line follicular NHL combined with chemotherapy and single-agent maintenance for responders; non-progressing low-grade NHL after first-line CVP; diffuse large B-cell lymphoma with CHOP or another anthracycline regimen; chronic lymphocytic leukaemia with fludarabine and cyclophosphamide; rheumatoid arthritis with methotrexate after an inadequate response to TNF antagonists; granulomatosis with polyangiitis and microscopic polyangiitis from 2 years of age; and moderate to severe pemphigus vulgaris. The Chinese label covers stage III-IV follicular NHL with chemotherapy, maintenance monotherapy, relapsed or chemo-resistant follicular lymphoma, DLBCL with CHOP, and CLL with fludarabine and cyclophosphamide. It is given by intravenous infusion only - never as a push or bolus.
Its US boxed warnings cover fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B reactivation and progressive multifocal leukoencephalopathy, so hepatitis B screening before treatment is mandatory and infusion must be monitored with resuscitative support available.
Rituximab is a biologic, so there is no generic or bioequivalence pathway: copies are approved as biosimilars and must demonstrate high similarity in structure, purity and biological activity plus comparative clinical data. The first biosimilars were approved in Europe in 2017, and Truxima became the first interchangeable rituximab biosimilar in the US on 1 July 2026, which blocks further interchangeable approvals for twelve months.
Rituximab price list — Bangladesh
Every DGDA-registered brand of this molecule with its list unit price, including the originator for comparison. Bangladesh is the most transparent reference market for on-patent generics.
| Brand | Manufacturer | Strength | Unit price | ≈ USD | Pack |
|---|---|---|---|---|---|
| Mabrix | ACI Limited | 10 mg/ml IV Infusion | — | — | — |
| Mabthera | Roche Bangladesh Ltd. | 10 mg/ml IV Infusion | — | — | — |
| Recelbia | Healthcare Pharmaceuticals Ltd. | 10 mg/ml IV Infusion | — | — | — |
| Relyto | Incepta Pharmaceuticals Ltd. | 10 mg/ml IV Infusion | — | — | — |
| Ritumab | Drug International Ltd. | 10 mg/ml IV Infusion | — | — | — |
| Rituris | Aristopharma Ltd. | 10 mg/ml IV Infusion | — | — | — |
| Rituxim | Beacon Pharmaceuticals PLC | 10 mg/ml IV Infusion | — | — | — |
| Truxima | ZAS Corporation (Mfg. by: Celltrion Pharma Inc, Korea) | 10 mg/ml IV Infusion | — | — | — |
Source: MedEx Bangladesh drug registry (list prices of DGDA-registered brands). Unit prices move with pack size, pharmacy and exchange rate — reference only. Original registry page
How it works
Rituximab attaches to CD20, a protein on the surface of B cells, and marks those cells for destruction by the immune system. Because both lymphoma cells and the B cells that drive autoimmune diseases such as rheumatoid arthritis carry CD20, the drug removes them - which is why it treats both blood cancers and autoimmune conditions.
Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab mediates B-cell lysis. Possible mechanisms of cell lysis include complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC). B cells are believed to play a role in the pathogenesis of rheumatoid arthritis and associated chronic synovitis, acting through production of rheumatoid factor and other autoantibodies, antigen presentation, T-cell activation and/or proinflammatory cytokine production.
Approved indications
- Non-Hodgkin's lymphoma (NHL): relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL as a single agent - FDA
- Previously untreated follicular, CD20-positive B-cell NHL in combination with first-line chemotherapy, and as single-agent maintenance therapy in patients achieving a complete or partial response - FDA
- Non-progressing (including stable disease), low-grade, CD20-positive B-cell NHL as a single agent after first-line CVP chemotherapy - FDA
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based regimens - FDA
- Chronic lymphocytic leukemia (CLL): previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC) - FDA
- Rheumatoid arthritis (RA): in combination with methotrexate in adults with moderately to severely active RA with inadequate response to one or more TNF antagonist therapies - FDA
- Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in adult and pediatric patients 2 years and older, in combination with glucocorticoids - FDA
- Moderate to severe pemphigus vulgaris (PV) in adults - FDA
- China label (美罗华): CD20-positive follicular NHL stage III-IV in combination with chemotherapy, maintenance monotherapy, relapsed/chemotherapy-resistant follicular lymphoma, DLBCL with standard CHOP, and CLL in combination with fludarabine and cyclophosphamide
Dosage & administration
NHL: 375 mg/m2 IV infusion. CLL: 375 mg/m2 in cycle 1 and 500 mg/m2 in cycles 2-6 with fludarabine/cyclophosphamide, every 28 days. RA (with methotrexate): two 1,000 mg IV infusions 2 weeks apart (one course) every 24 weeks, not sooner than every 16 weeks, with methylprednisolone 100 mg IV or equivalent 30 minutes before each infusion. GPA/MPA induction (adults): 375 mg/m2 once weekly for 4 weeks; follow-up two 500 mg IV infusions 2 weeks apart then 500 mg every 6 months. Paediatric GPA/MPA induction: 375 mg/m2 weekly for 4 weeks; follow-up 250 mg/m2. PV: two 1,000 mg IV infusions 2 weeks apart with tapering glucocorticoids, then 500 mg at month 12 and every 6 months; relapse dose 1,000 mg IV. IV infusion only - never IV push or bolus.
Dose adjustment
No dosage adjustment is specified for renal or hepatic impairment in the US label; withhold rituximab and institute anti-infective therapy for infections, discontinue infusion for serious or life-threatening cardiac events, and discontinue in patients with rising serum creatinine or oliguria. Do not use with other biologic agents or DMARDs other than methotrexate in RA, GPA, MPA and PV. In CLL patients older than 70 years, exploratory analyses suggested no benefit from adding rituximab to FC. Consult the specific product label for tumour lysis syndrome prophylaxis and premedication (antihistamine/antipyretic) requirements.
Side effects
Hypotension, nausea, body aches, tiredness, asthenia
- Infusion-related reactions (fever, chills, rigors, hypotension, urticaria) - approximately 80% of fatal reactions occurred with the first infusion
- Infections (bacterial, fungal and viral; serious infections can be fatal; prolonged low antibody levels for longer than 11 months have been reported)
- Hepatitis B virus reactivation, including fulminant hepatitis and hepatic failure
- Progressive multifocal leukoencephalopathy (PML), which can be fatal
- Severe mucocutaneous reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, paraneoplastic pemphigus)
- Tumour lysis syndrome
- Cardiac adverse reactions, including chest pain, arrhythmias and heart failure
- Renal toxicity, including severe kidney injury in NHL
- Bowel obstruction and perforation
- Cytopenias: lymphopenia, neutropenia, thrombocytopenia, anaemia
Fatal infusion-related reactions (approximately 80% of fatal reactions occurred with the first infusion; deaths within 24 hours of infusion have occurred); severe mucocutaneous reactions, some fatal; hepatitis B virus reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death; progressive multifocal leukoencephalopathy (PML), including fatal cases.
Monitoring
- Screen all patients for hepatitis B infection before treatment initiation and monitor during and after treatment
- Close monitoring during infusion for infusion-related reactions, with medical support immediately available to manage severe reactions
- Monitor for infection and for symptoms of PML (neurological, cognitive or behavioural changes)
- Monitor renal function (rising creatinine, oliguria) - discontinue if these occur
- Monitor for cardiac adverse reactions, especially in patients with pre-existing cardiac disease or arrhythmias
- Laboratory monitoring for tumour lysis syndrome (including within 12-24 hours of infusion in high-risk patients)
- CBC monitoring for cytopenias and infections
- Monitor for bowel obstruction or perforation in patients receiving rituximab with chemotherapy
- Vaccination: live virus vaccines are not recommended prior to or during treatment; screen for latent tuberculosis and hepatitis before treating autoimmune indications
- Advise effective contraception in females of reproductive potential (embryo-fetal toxicity); advise not to breastfeed
Generic and biosimilar landscape
Rituximab is a biologic, so there is no generic/bioequivalence pathway: copies are approved as biosimilars (or 'similar biologics' in India) and must demonstrate high similarity in structure, purity and biological activity plus comparative clinical data against the reference product (MabThera/Rituxan). The first rituximab biosimilars were approved by the EMA in 2017 (Truxima in February 2017; Rixathon/Riximyo on 19 June 2017). India's 'similar biologics' pathway predates its 2012 guidelines: Dr Reddy's Reditux was approved by CDSCO in 2007 and is described as the world's first rituximab biosimilar. Note on attribution: RituxiRel, often misattributed to Biocon, is developed and marketed by Reliance Life Sciences (approved in India in February 2015); no evidence was found in the retrieved sources for a Biocon rituximab biosimilar. US: no 180-day ANDA exclusivity applies (that framework is for small-molecule generics); under the BPCIA the first interchangeable biosimilar receives a 12-month exclusivity - Truxima became the first interchangeable rituximab biosimilar in the US on 1 July 2026, and the FDA cannot approve another interchangeable rituximab during that period.
Who makes it
| Manufacturer | Country | Brand | Strength | Notes |
|---|---|---|---|---|
| Dr. Reddy's Laboratories Ltd. | India | Reditux | 100 mg/10 mL and 500 mg/50 mL vials | Approved by CDSCO in 2007 and described as the world's first rituximab biosimilar; launched at about 50% of the originator price in India |
| Reliance Life Sciences Pvt. Ltd. | India | RituxiRel | 100 mg/10 mL and 500 mg/50 mL single-use vials | Approved in India in February 2015 for NHL, CLL, RA, GPA and pemphigus vulgaris |
| Celltrion, Inc. | South Korea | Truxima (rituximab-abbs) | 100 mg/10 mL and 500 mg/50 mL vials | EMA approval 17 February 2017; FDA approval November 2018; US launch 11 November 2019; first interchangeable rituximab biosimilar in the US (July 2026) |
| Sandoz | Switzerland | Rixathon / Riximyo (GP2013) | 100 mg and 500 mg vials | European Commission approval 19 June 2017; Sandoz decided not to pursue the US rituximab market |
| Intas Pharmaceuticals Ltd. | India | Mabtas / Maball | 100 mg and 500 mg vials | CDSCO-approved rituximab biosimilars marketed in India |
| Beacon Pharmaceuticals PLC | Bangladesh | Rituxim | 10 mg/mL, 100 mg and 500 mg vials | Locally manufactured; listed on MedEx Bangladesh |
| Incepta Pharmaceuticals Ltd. | Bangladesh | Relyto | 10 mg/mL, 100 mg and 500 mg vials | Locally manufactured; listed on MedEx Bangladesh |
| Healthcare Pharmaceuticals Ltd. | Bangladesh | Recelbia | 10 mg/mL, 100 mg and 500 mg vials | Locally manufactured; listed on MedEx Bangladesh |
| ACI Limited | Bangladesh | Mabrix | 10 mg/mL, 100 mg and 500 mg vials | Locally manufactured; listed on MedEx Bangladesh |
Availability in Southeast Asia
| Country | Status | Notes |
|---|---|---|
| Bangladesh | available - originator and multiple local biosimilars | MedEx lists Mabthera (Roche Bangladesh) alongside locally made Rituxim, Relyto, Recelbia, Mabrix, Ritumab, Rituris and imported Truxima (Celltrion), with published prices |
| Malaysia | not confirmed | |
| Indonesia | not confirmed | |
| Thailand | not confirmed | |
| Philippines | not confirmed | |
| Vietnam | not confirmed |
Price by country
Reference prices by market
| Market | Product | Listed price | Source |
|---|---|---|---|
| Bangladesh | Mabthera (Roche Bangladesh Ltd.) rituximab IV infusion | BDT 12,610.00 per 100 mg vial; BDT 69,957.60 per 500 mg vial | medex.com.bd |
| Bangladesh | Rituxim (Beacon Pharmaceuticals PLC) | BDT 11,000.00 per 100 mg vial; BDT 55,000.00 per 500 mg vial | medex.com.bd |
| Bangladesh | Relyto (Incepta Pharmaceuticals Ltd.) | BDT 13,000.00 per 100 mg vial; BDT 60,000.00 per 500 mg vial | medex.com.bd |
| Bangladesh | Truxima (Celltrion, distributed by ZAS Corporation) | BDT 13,500.00 per 100 mg vial; BDT 58,000.00 per 500 mg vial | medex.com.bd |
| India | Rituximab brands (Maball, Mabtas, Reditux, Cytomab, Ikgdar and others) - price range by brand | approximately INR 7,031 to INR 71,338 per vial depending on brand and strength (100 mg vs 500 mg) | 1mg.com |
| India | RituxiRel (Reliance Life Sciences) 100 mg / 500 mg injection - IndiaMART listed prices | INR 3,500 - 34,910 per vial depending on strength and seller (100 mg around INR 3,000-3,500; 500 mg around INR 26,000-34,910) | dir.indiamart.com |
Frequently asked questions
What is the difference between Rituxan, MabThera and rituximab biosimilars?
Rituximab is a biologic, so there is no generic/bioequivalence pathway: copies are approved as biosimilars (or 'similar biologics' in India) and must demonstrate high similarity in structure, purity and biological activity plus comparative clinical data against the reference product (MabThera/Rituxan). The first rituximab biosimilars were approved by the EMA in 2017 (Truxima in February 2017; Rixathon/Riximyo on 19 June 2017). India's 'similar biologics' pathway predates its 2012 guidelines: Dr Reddy's Reditux was approved by CDSCO in 2007 and is described as the world's first rituximab biosimilar. Note on attribution: RituxiRel, often misattributed to Biocon, is developed and marketed by Reliance Life Sciences (approved in India in February 2015); no evidence was found in the retrieved sources for a Biocon rituximab biosimilar. US: no 180-day ANDA exclusivity applies (that framework is for small-molecule generics); under the BPCIA the first interchangeable biosimilar receives a 12-month exclusivity - Truxima became the first interchangeable rituximab biosimilar in the US on 1 July 2026, and the FDA cannot approve another interchangeable rituximab during that period. Manufacturers supplying rituximab generic versions include ACI Limited, Beacon Pharmaceuticals PLC, Celltrion, Inc., Dr. Reddy's Laboratories Ltd., Healthcare Pharmaceuticals Ltd., Incepta Pharmaceuticals Ltd., Intas Pharmaceuticals Ltd., Reliance Life Sciences Pvt. Ltd.. Brands registered in Bangladesh include Mabrix, Mabthera, Recelbia, Relyto, Ritumab, Rituris.
Is rituximab a generic or a biosimilar and can it be substituted at the pharmacy?
Rituximab is a biologic, so there is no generic/bioequivalence pathway: copies are approved as biosimilars (or 'similar biologics' in India) and must demonstrate high similarity in structure, purity and biological activity plus comparative clinical data against the reference product (MabThera/Rituxan). The first rituximab biosimilars were approved by the EMA in 2017 (Truxima in February 2017; Rixathon/Riximyo on 19 June 2017). India's 'similar biologics' pathway predates its 2012 guidelines: Dr Reddy's Reditux was approved by CDSCO in 2007 and is described as the world's first rituximab biosimilar. Note on attribution: RituxiRel, often misattributed to Biocon, is developed and marketed by Reliance Life Sciences (approved in India in February 2015); no evidence was found in the retrieved sources for a Biocon rituximab biosimilar. US: no 180-day ANDA exclusivity applies (that framework is for small-molecule generics); under the BPCIA the first interchangeable biosimilar receives a 12-month exclusivity - Truxima became the first interchangeable rituximab biosimilar in the US on 1 July 2026, and the FDA cannot approve another interchangeable rituximab during that period. Manufacturers supplying rituximab generic versions include ACI Limited, Beacon Pharmaceuticals PLC, Celltrion, Inc., Dr. Reddy's Laboratories Ltd., Healthcare Pharmaceuticals Ltd., Incepta Pharmaceuticals Ltd., Intas Pharmaceuticals Ltd., Reliance Life Sciences Pvt. Ltd.. Brands registered in Bangladesh include Mabrix, Mabthera, Recelbia, Relyto, Ritumab, Rituris.
What is the price of rituximab 500 mg in Bangladesh and India?
Bangladesh unit prices for rituximab are not published per unit; the registry lists pack prices only. Prices move with pack size, pharmacy and the exchange rate — confirm current stock and price with a licensed importer before ordering.
When did the rituximab (MabThera) patent expire and when did biosimilars launch?
Rituximab is a biologic, so there is no generic/bioequivalence pathway: copies are approved as biosimilars (or 'similar biologics' in India) and must demonstrate high similarity in structure, purity and biological activity plus comparative clinical data against the reference product (MabThera/Rituxan). The first rituximab biosimilars were approved by the EMA in 2017 (Truxima in February 2017; Rixathon/Riximyo on 19 June 2017). India's 'similar biologics' pathway predates its 2012 guidelines: Dr Reddy's Reditux was approved by CDSCO in 2007 and is described as the world's first rituximab biosimilar. Note on attribution: RituxiRel, often misattributed to Biocon, is developed and marketed by Reliance Life Sciences (approved in India in February 2015); no evidence was found in the retrieved sources for a Biocon rituximab biosimilar. US: no 180-day ANDA exclusivity applies (that framework is for small-molecule generics); under the BPCIA the first interchangeable biosimilar receives a 12-month exclusivity - Truxima became the first interchangeable rituximab biosimilar in the US on 1 July 2026, and the FDA cannot approve another interchangeable rituximab during that period. Manufacturers supplying rituximab generic versions include ACI Limited, Beacon Pharmaceuticals PLC, Celltrion, Inc., Dr. Reddy's Laboratories Ltd., Healthcare Pharmaceuticals Ltd., Incepta Pharmaceuticals Ltd., Intas Pharmaceuticals Ltd., Reliance Life Sciences Pvt. Ltd.. Brands registered in Bangladesh include Mabrix, Mabthera, Recelbia, Relyto, Ritumab, Rituris.
What is the dose of rituximab for non-Hodgkin lymphoma and rheumatoid arthritis?
Standard dosing for rituximab: NHL: 375 mg/m2 IV infusion. CLL: 375 mg/m2 in cycle 1 and 500 mg/m2 in cycles 2-6 with fludarabine/cyclophosphamide, every 28 days. RA (with methotrexate): two 1,000 mg IV infusions 2 weeks apart (one course) every 24 weeks, not sooner than every 16 weeks, with methylprednisolone 100 mg IV or equivalent 30 minutes before each infusion. GPA/MPA induction (adults): 375 mg/m2 once weekly for 4 weeks; follow-up two 500 mg IV infusions 2 weeks apart then 500 mg every 6 months. Paediatric GPA/MPA induction: 375 mg/m2 weekly for 4 weeks; follow-up 250 mg/m2. PV: two 1,000 mg IV infusions 2 weeks apart with tapering glucocorticoids, then 500 mg at month 12 and every 6 months; relapse dose 1,000 mg IV. IV infusion only - never IV push or bolus. Dose adjustments: No dosage adjustment is specified for renal or hepatic impairment in the US label; withhold rituximab and institute anti-infective therapy for infections, discontinue infusion for serious or life-threatening cardiac events, and discontinue in patients with rising serum creatinine or oliguria. Do not use with other biologic agents or DMARDs other than methotrexate in RA, GPA, MPA and PV. In CLL patients older than 70 years, exploratory analyses suggested no benefit from adding rituximab to FC. Consult the specific product label for tumour lysis syndrome prophylaxis and premedication (antihistamine/a
How long does rituximab stay in the body after an infusion?
Elimination half-life: NHL: median terminal elimination half-life approximately 22 days (range 6.1 to 52 days) in a population analysis of 298 NHL patients. RA: mean terminal elimination half-life 18.0 days (range 5.17 to 77.5 days); clearance 0.335 L/day; volume of distribution 3.1 L.. Dosing intervals are designed around this, which is why most regimens are once or twice daily.
What are the boxed warnings for rituximab and why must hepatitis B be tested first?
Recommended monitoring for rituximab: Screen all patients for hepatitis B infection before treatment initiation and monitor during and after treatment; Close monitoring during infusion for infusion-related reactions, with medical support immediately available to manage severe reactions; Monitor for infection and for symptoms of PML (neurological, cognitive or behavioural changes); Monitor renal function (rising creatinine, oliguria) - discontinue if these occur; Monitor for cardiac adverse reactions, especially in patients with pre-existing cardiac disease or arrhythmias; Laboratory monitoring for tumour lysis syndrome (including within 12-24 hours of infusion in high-risk patients); CBC monitoring for cytopenias and infections; Monitor for bowel obstruction or perforation in patients receiving rituximab with chemotherapy; Vaccination: live virus vaccines are not recommended prior to or during treatment; screen for latent tuberculosis and hepatitis before treating autoimmune indications; Advise effective contraception in females of reproductive potential (embryo-fetal toxicity); advise not to breastfeed
Is RituxiRel made by Biocon or Reliance Life Sciences?
Rituximab (CD20-directed cytolytic monoclonal antibody; chimeric murine/human IgG1 kappa antibody (biologic, not a small-molecule generic), originally Rituxan (US) / MabThera (EU and most ex-US markets; Chinese brand name 美罗华) by Genentech, Inc. (a member of the Roche Group), with Biogen; Rituxan is jointly marketed by Biogen and Genentech USA in the US; MabThera is marketed by Roche) Rituximab attaches to CD20, a protein on the surface of B cells, and marks those cells for destruction by the immune system. Because both lymphoma cells and the B cells that drive autoimmune diseases such as rheumatoid arthritis carry CD20, the drug removes them - which is why it treats both blood cancers and autoimmune conditions. NHL: 375 mg/m2 IV infusion. CLL: 375 mg/m2 in cycle 1 and 500 mg/m2 in cycles 2-6 with fludarabine/cyclophosphamide, every 28 days. RA (with methotrexate): two 1,000 mg IV infusions 2 weeks apart (one course) every 24 weeks, not sooner than every 16 weeks, with methylprednisolone 100 mg IV or equivalent 30 minutes before each infusion. GPA/MPA induction (adults): 375 mg/m2 once weekly for 4 weeks;
How should rituximab vials be stored and how long is a diluted infusion stable?
Storage: Store rituximab vials refrigerated at 2 degrees C to 8 degrees C (36-46 degrees F). Protect from direct sunlight. Do not freeze or shake. Diluted rituximab solutions for infusion may be stored refrigerated at 2-8 degrees C for 24 hours and are stable for an additional 24 hours at room temperature, but solutions contain no preservative. Supplied as 100 mg/10 mL and 500 mg/50 mL single-dose vials. Keep the product in its original packaging and check the expiry date printed on the pack.
Which rituximab biosimilars are approved in India and who makes them?
Rituximab is a biologic, so there is no generic/bioequivalence pathway: copies are approved as biosimilars (or 'similar biologics' in India) and must demonstrate high similarity in structure, purity and biological activity plus comparative clinical data against the reference product (MabThera/Rituxan). The first rituximab biosimilars were approved by the EMA in 2017 (Truxima in February 2017; Rixathon/Riximyo on 19 June 2017). India's 'similar biologics' pathway predates its 2012 guidelines: Dr Reddy's Reditux was approved by CDSCO in 2007 and is described as the world's first rituximab biosimilar. Note on attribution: RituxiRel, often misattributed to Biocon, is developed and marketed by Reliance Life Sciences (approved in India in February 2015); no evidence was found in the retrieved sources for a Biocon rituximab biosimilar. US: no 180-day ANDA exclusivity applies (that framework is for small-molecule generics); under the BPCIA the first interchangeable biosimilar receives a 12-month exclusivity - Truxima became the first interchangeable rituximab biosimilar in the US on 1 July 2026, and the FDA cannot approve another interchangeable rituximab during that period. Manufacturers supplying rituximab generic versions include ACI Limited, Beacon Pharmaceuticals PLC, Celltrion, Inc., Dr. Reddy's Laboratories Ltd., Healthcare Pharmaceuticals Ltd., Incepta Pharmaceuticals Ltd., Intas Pharmaceuticals Ltd., Reliance Life Sciences Pvt. Ltd.. Brands registered in Bangladesh include Mabrix, Mabthera, Recelbia, Relyto, Ritumab, Rituris.
Sources
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5464lbl.pdf
- https://www.rituxan-hcp.com
- https://www.roche.com/solutions/pharma/productid-b0eb216f-addf-4ed1-b01e-0b12fe0b1ef6
- https://medex.com.bd/generics/962/rituximab/brand-names
- https://www.1mg.com/generics/rituximab-211176
- https://dir.indiamart.com/impcat/rituxan.html
- https://www.ema.europa.eu/en/medicines/human/EPAR/truxima
- https://www.bigmoleculewatch.com/2026/07/09/celltrion-and-tevas-truxima-becomes-first-interchangeable-rituximab-biosimilar-in-u-s
- https://www.tevapharm.com/news-and-media/latest-news/teva-and-celltrion-announce-the-availability-of-truxima-rituximab-abbs-injection-the-first-biosimilar
- https://www.gabionline.net/biosimilars/general/Biosimilars-of-rituximab
- https://www.gabionline.net/biosimilars/research/Rituximab-similar-biologic-shows-equivalent-efficacy-and-safety
- https://www.rellife.com/web/lifesciences/rituxirel
- https://www.cioncancerclinics.com/chemotherapy/generics/rituximab-biosimilars-india
- https://www.bigmoleculewatch.cn/2023/06/05/%E6%AD%A3%E5%A4%A7%E5%A4%A9%E6%99%B4%E5%88%A9%E5%A6%A5%E6%98%94%E5%8D%95%E6%8A%97%E7%94%9F%E7%89%A9%E7%B1%BB%E4%BC%BC%E8%8D%AF%E8%8E%B7%E6%89%B9%E4%B8%8A%E5%B8%82
- https://www.biosimilarsip.com/2017/06/29/sandozs-rixathon-rituximab-approved-europe
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