Rituximab biosimilars
An antibody that removes B cells, used in lymphoma, leukaemia and rheumatoid arthritis, and the first antibody ever copied as a biosimilar.
About rituximab
Rituximab is an antibody that targets CD20, a marker on the surface of B cells. It was the first antibody approved for cancer, in the late 1990s, and later found a second life in rheumatoid arthritis and other immune diseases.
It attaches to B cells and destroys them in three ways: by calling in immune cells, by activating complement proteins in the blood, and by triggering the cell to die. All three depend on the tail of the antibody, so that part has to be matched very closely in a biosimilar.
It is an infusion into a vein, from vials in two sizes. The dose and schedule depend on the disease.
Non-Hodgkin lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis after other treatments have failed, and two forms of blood vessel inflammation.
Because all of rituximab's actions run through the antibody's tail, the laboratory comparison is the heart of the assessment. A clinical comparison is done in either rheumatoid arthritis or lymphoma, and regulators extend the result to the other uses once the laboratory data match.
The reference product is MabThera in Europe and Rituxan in the United States, from Roche. Patents expired in Europe in 2013 and in the United States a few years later.
Rituximab was the first cancer antibody to be copied. India was first, with products in 2007 and 2013; Europe approved the first antibody biosimilar for cancer in 2017; the United States followed in 2018. India remains the deepest market, with six domestic makers.
Clinical details are summarised from the reference product's prescribing information. Approval dates, numbers and presentations are in the tables below, each with its source.
Competitive outlook
- Todaytwelve rituximab biosimilars are approved in at least one of the seven markets.
- Nearest to marketHLX01, MabionCD20, RTXM83, SIBP-02 have reached phase 3, the last trial before a filing.
- Further outRitumax is still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from twelve to seventeen.
3 published switching studies with rituximab biosimilars, and where evidence is still missing.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| FDA | Truxima | CELLTRION, Inc. | Nov 2018 | 761088 | Interchangeable | Approved | S001, S016 |
| FDA | Ruxience | Pfizer Ireland Pharmaceuticals Unlimited Company | Jul 2019 | 761103 | Biosimilar | Approved | S001, S016 |
| FDA | Riabni | Amgen Inc. | Dec 2020 | 761140 | Biosimilar | Approved | S001, S016 |
| FDA | Zimrixby | Dr. Reddy's Laboratories SA | Jul 2026 | 761376 | Biosimilar | Approved | S001, S016 |
| EMA | Truxima | Celltrion Healthcare Hungary Kft. | Feb 2017 | EMEA/H/C/004112 | Approved | S017 | |
| EMA | Rixathon | Sandoz GmbH | Jun 2017 | EMEA/H/C/003903 | Approved | S017 | |
| EMA | Riximyo | Sandoz GmbH | Jun 2017 | EMEA/H/C/004729 | Approved | S017 | |
| EMA | Blitzima | Celltrion Healthcare Hungary Kft. | Jul 2017 | EMEA/H/C/004723 | Approved | S017 | |
| EMA | Ritemvia | Celltrion Healthcare Hungary Kft. | Jul 2017 | EMEA/H/C/004725 | Withdrawn | S017 | |
| EMA | Rituzena | Celltrion Healthcare Hungary Kft. | Jul 2017 | EMEA/H/C/004724 | Withdrawn | S017 | |
| EMA | Ruxience | Pfizer Europe MA EEIG | Apr 2020 | EMEA/H/C/004696 | Approved | S017 | |
| EMA | Ituxredi | Reddy Holding GmbH | Sep 2024 | EMEA/H/C/006224 | Approved | S017 | |
| MHRA | Ituxredi | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Rixathon | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ruxience | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Truxima | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Rituximab BS [KHK] | Sandoz K.K. (co-developed with Kyowa Kirin) | Sep 2017 | not published | Approved | S020 | |
| PMDA | Rituximab BS [Pfizer] | Pfizer Japan | Sep 2019 | not published | Approved | S020 | |
| HC | Truxima | Celltrion INC. | Apr 2019 | DIN 02478382, 02478390 | Approved | S022 | |
| HC | Riximyo | Sandoz Canada Incorporated | Apr 2020 | DIN 02498316 | Approved | S022 | |
| HC | Ruxience | Pfizer Canada ULC | May 2020 | DIN 02495724 | Approved | S022 | |
| HC | Riabni | Amgen Canada INC | Mar 2021 | DIN 02513447 | Withdrawn | S022 | |
| CDSCO | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals Ltd | Feb 2013 | MF-05/2013 | Approved | S014 | |
| CDSCO | Zenotech Laboratories (INN only) | Zenotech Laboratories Ltd | Feb 2013 | MF-36/2013 | Approved | S014 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Feb 2015 | MF-17/2015 | Approved | S014 | |
| CDSCO | Hetero Drugs (INN only) | Hetero Drugs Limited | Mar 2015 | MF-76/2015 | Approved | S014 | |
| CDSCO | Biocad India (INN only) | Biocad India Pvt Ltd | Jul 2017 | Import permission | Approved | S013 | |
| CDSCO | Zydus Lifesciences (INN only) | Zydus Lifesciences Limited | Jun 2025 | MF/BIO/25/000093 | Approved | S011 | |
| CDSCO | Virchow Biotech Private (INN only) | Virchow Biotech Private Limited | Aug 2025 | MF/BIO/25/000114 | Approved | S011 | |
| EDE | Rixathon | Lek Pharmaceuticals d.d., Slovenia (Sandoz) | Mar 2019 | not published | Registered | S018 | |
| EDE | Truxima | Hikma Pharmaceuticals, Jordan (for Celltrion) | Apr 2020 | not published | Registered | S018 | |
| EDE | Ruxience | Pfizer Manufacturing Belgium NV | Feb 2021 | not published | Registered | S018 |
Last checked Sep 2026. US interchangeability designations are listed in full on the interchangeable biosimilars page. CDSCO lists permissions by firm and INN, not brand. PMDA's list and the UAE directory do not publish application numbers; Canadian dates are the first approval or market date recorded in the Drug Product Database.
Regulatory pathway by market
Requirements for a rituximab biosimilar under the guidance in force in September 2026.
| FDA, United States | EMA, European Union | MHRA, United Kingdom | PMDA, Japan | Health Canada | CDSCO, India | EDE, UAE | |
|---|---|---|---|---|---|---|---|
| Legal pathway | Section 351(k) of the Public Health Service Act (BPCIA 2009) | Article 10(4) of Directive 2001/83/EC; centralised procedure is mandatory for biotechnology products | UK marketing authorisation from MHRA. EU approvals in force at the end of 2020 became Great Britain licences automatically; new products since 2021 are approved through reliance on EMA or FDA decisions, and from 2024 through the International Recognition Procedure. Northern Ireland follows EU licences | MHLW approval on PMDA review under the Guideline for Ensuring Quality, Safety and Efficacy of Biosimilars (2009, revised 2020), with Q&A updates in 2024 and 2026 | Notice of Compliance under the Food and Drug Regulations as a biosimilar biologic drug, assessed under Health Canada's guidance on biosimilars (2016, revised 2022 and 2026) | Guidelines on Similar Biologics (CDSCO and DBT, 2016, in force); revised draft published May 2025 | Registration through the Emirates Drug Establishment; the public directory does not distinguish biosimilars from other biologicals |
| Reference product | US-licensed reference; a non-US comparator may be used with analytical and PK bridging | EU-authorised reference; a non-EEA comparator may be used with bridging data | Reference biologic authorised in the UK, or an EU-authorised version with bridging data | The original biopharmaceutical approved in Japan; foreign-sourced reference accepted with bridging since the 2020 revision | Reference biologic drug authorised in Canada, or a non-Canadian version of it with bridging data | Product licensed in India, or if not, one licensed in an ICH country, with justification | Not stated in the public directory; registration relies on assessment by reference regulators |
| Comparative clinical study | Draft guidance (October 2025): comparative analytical assessment plus a PK similarity study and immunogenicity assessment; a comparative efficacy study is generally not needed | Reflection paper adopted March 2026: a comparative efficacy trial can be waived when analytical and PK comparability is sufficient | Follows the EU guideline; MHRA's 2021 biosimilar guidance states that a comparative efficacy trial is generally not needed where analytical and pharmacokinetic comparability is shown | Comparative PK study and, in principle, a comparative efficacy study; the May 2026 early consideration sets out when the efficacy study can be omitted, and Japanese patient data are no longer required in every case (2025) | Comparative structural and functional studies, PK and, where warranted, PD equivalence; the 2026 revision reduces the expectation of comparative efficacy trials in line with FDA and EMA | Comparative PK/PD study and a comparative safety and efficacy study are generally expected, followed by a post-marketing study | Assessed on the dossier accepted by the reference regulator |
| Interchangeability | A separate designation permitting pharmacy-level substitution; switching studies generally not required under the June 2024 draft | EMA and HMA statement (September 2022): EU biosimilars are interchangeable with their reference; substitution rules are set by each member state | No designation; MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by the prescriber and by NHS commissioning | Not defined; prescribing by brand, with pharmacist substitution not automatic | No federal designation; substitution and mandatory switching policies are set by each province, several of which have required switching since 2019 | Not defined in the guidelines | Not defined |
| Naming | INN plus a four-letter suffix | INN, identical to the reference; brand name and batch recorded for pharmacovigilance | Brand name with the non-proprietary name; licence numbers PL, PLGB or PLNI | INN followed by BS (biosimilar), strength, form and the company name in quotation marks, with a biosimilar number in the non-proprietary name | Non-proprietary name identical to the reference, with brand name and DIN as identifiers | INN with the brand name | Brand name as registered |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs; MHRA guidance on the licensing of biosimilar products (2021).
EvySaif prepares the comparative evidence plan and the regional dossier strategy for rituximab programmes. Regulatory strategy consulting
Presentations and concentration
All presentations are 10 mg/mL concentrate for infusion; 100 mg in 10 mL and 500 mg in 50 mL single-use vials.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Truxima / Blitzima CT-P10 | 100 mg/10 mL, 500 mg/50 mL | see SmPC | 100 mg and 500 mg vials | · | 100, 500 mg | · | 100 mg/10 mL, 500 mg/50 mL |
| Rixathon / Riximyo GP2013 | · | see SmPC | 100 mg and 500 mg vials | 100 mg and 500 mg vials | 10 mg | · | 100 mg/10 mL, 500 mg/50 mL |
| Ruxience PF-05280586 | 100 mg/10 mL, 500 mg/50 mL | see SmPC | 100 mg and 500 mg vials | 100 mg and 500 mg vials | 10 mg | · | 100 mg/10 mL, 500 mg/50 mL |
| Riabni ABP 798 | 100 mg/10 mL, 500 mg/50 mL | · | · | · | 10 mg | · | · |
| Zimrixby / Ituxredi DRL_RI | 100 mg/10 mL, 500 mg/50 mL | see SmPC | 100 mg and 500 mg vials | · | · | · | · |
| Zenotech rituximab | · | · | · | · | · | 100 mg/10 mL and 500 mg/50 mL vials | · |
| Intas rituximab | · | · | · | · | · | 100 mg and 500 mg vials (10 mg/mL) | · |
| Reliance Life Sciences rituximab | · | · | · | · | · | 100 mg/10 mL and 500 mg/50 mL vials | · |
| Hetero rituximab | · | · | · | · | · | 100 mg/10 mL and 500 mg/50 mL vials | · |
| Zydus rituximab | · | · | · | · | · | 100 mg/10 mL and 500 mg/50 mL (10 mg/mL) | · |
| Virchow Biotech rituximab | · | · | · | · | · | 100 mg/10 mL and 500 mg/50 mL | · |
| Biocad rituximab BCD-020 | · | · | · | · | · | 100 mg and 500 mg vials | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Celltrion | Truxima / Blitzima | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Sandoz | Rixathon / Riximyo | · | ✓ | ✓ | ✓ | ✓ | · | ✓ |
| Pfizer | Ruxience | ✓ | ✓ | ✓ | ✓ | ✓ | · | ✓ |
| Amgen | Riabni | ✓ | · | · | · | withdrawn | · | · |
| Dr. Reddy's Laboratories | Zimrixby / Ituxredi | ✓ | ✓ | ✓ | · | · | · | · |
| Zenotech Laboratories | Zenotech rituximab | · | · | · | · | · | ✓ | · |
| Intas Pharmaceuticals | Intas rituximab | · | · | · | · | · | ✓ | · |
| Reliance Life Sciences | Reliance Life Sciences rituximab | · | · | · | · | · | ✓ | · |
| Hetero Drugs | Hetero rituximab | · | · | · | · | · | ✓ | · |
| Zydus Lifesciences | Zydus rituximab | · | · | · | · | · | ✓ | · |
| Virchow Biotech | Virchow Biotech rituximab | · | · | · | · | · | ✓ | · |
| Biocad | Biocad rituximab | · | · | · | · | · | ✓ | · |
Entering a market where a competitor is already listed changes the evidence and pricing conversation. EvySaif's global value dossier and HTA submission work covers that side.
Products
Truxima / Blitzima
Rixathon / Riximyo
Ruxience
Riabni
Zimrixby / Ituxredi
Zenotech rituximab
Intas rituximab
Reliance Life Sciences rituximab
Hetero rituximab
Zydus rituximab
Virchow Biotech rituximab
Biocad rituximab
In development
ClinicalTrials.gov holds twelve comparative trials of nine rituximab biosimilar candidates against the reference product, run by nine sponsors. Five of the candidates (HLX01, MabionCD20, RTXM83, Ritumax, SIBP-02) have no approval yet in any of the seven markets, so they show where the next competition may come from. Trials are listed with the sponsor's own wording for status and dates.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|
| BCD-020 | Biocad | MabThera | Phase 3 | Comparative efficacy | Completed | Dec 2012 | Jul 2015 | Biocad rituximab | NCT01759030 |
| BCD-020 | Biocad | MabThera | Phase 3 | Comparative efficacy | Completed | Sep 2011 | Jan 2017 | Biocad rituximab | NCT01701232 |
| Ritumax | Biointegrator | MabThera | Phase 1 | Comparative PK | Terminated | Oct 2016 | Mar 2018 | no approval in the seven markets | NCT03061838 |
| CT-P10 | Celltrion | MabThera | Phase 1 | Comparative PK | Completed | Feb 2012 | Aug 2013 | Truxima / Blitzima | NCT01534884 |
| DRL_RI | Dr. Reddy's Laboratories | MabThera | Phase 3 | Comparative efficacy | Completed | Apr 2020 | Jan 2022 | Zimrixby / Ituxredi | NCT04268771 |
| DRL_RI | Dr. Reddy's Laboratories | MabThera | Phase 3 | Comparative efficacy | Completed | May 2019 | Sep 2022 | Zimrixby / Ituxredi | NCT03976102 |
| MabionCD20 | Mabion | MabThera | Phase 3 | Comparative efficacy | Withdrawn | Aug 2023 | Aug 2023 | no approval in the seven markets | NCT04680962 |
| GP2013 | Sandoz | MabThera | Phase 3 | Comparative efficacy | Completed | Dec 2011 | Jul 2015 | Rixathon / Riximyo | NCT01419665 |
| GP2013 | Sandoz | MabThera | Phase 3 | Comparative efficacy | Completed | Jul 2015 | Jul 2016 | Rixathon / Riximyo | NCT02514772 |
| HLX01 | Shanghai Henlius Biotech | MabThera (brand not stated) | Phase 3 | Comparative efficacy | Completed | Oct 2015 | May 2018 | no approval in the seven markets | NCT02787239 |
| SIBP-02 | Shanghai Institute of Biological Products | MabThera (brand not stated) | Phase 3 | Comparative efficacy | Completed | Jul 2019 | May 2022 | no approval in the seven markets | NCT04361279 |
| RTXM83 | mAbxience | MabThera | Phase 3 | Comparative efficacy | Completed | May 2013 | May 2016 | no approval in the seven markets | NCT02268045 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026. The full list across all molecules is on the pipeline page.
Questions
Which was the first rituximab biosimilar?
Dr. Reddy's Reditux in India, launched in 2007, is widely reported as the first in the world. Europe's first was Truxima in 2017.
Is there a rituximab biosimilar given under the skin?
No. All biosimilars are infusions. The under-the-skin version of the original is a separate product.
Are rituximab biosimilars interchangeable in the United States?
One is: Truxima, designated in 2026. The others are not.
Which rituximab biosimilars are registered in the UAE?
Three European products, from Sandoz, Celltrion and Pfizer, alongside MabThera.
How is a rituximab biosimilar tested?
Detailed laboratory comparison of how the antibody kills cells, a study of how it behaves in the body, and a clinical comparison in rheumatoid arthritis or lymphoma.
Which companies make rituximab in India?
Intas, Zenotech, Reliance, Hetero, Zydus and Virchow hold permissions, and Dr. Reddy's has sold its product since before the published lists begin.
Work with EvySaif on rituximab
Rituximab biosimilar landscape report
The register on this page as a delivered document: every approval, holder, presentation and pathway requirement across FDA, EMA, CDSCO and the Gulf, updated to the month, with the sources attached.
Request the landscape reportRegulatory gap assessment
For a developer deciding whether and where to file: a review of your analytical, PK and clinical package against what each regulator expects for rituximab, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)S024ClinicalTrials.gov, study records (API v2, one query per molecule with the term biosimilar) Registry (sponsor-entered)
Planning rituximab biosimilar development?
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