Tocilizumab biosimilars
An antibody that blocks interleukin-6, used in rheumatoid arthritis and several rarer conditions and, during the pandemic, in severe COVID-19.
About tocilizumab
Tocilizumab is an antibody that blocks the receptor for interleukin-6, a signalling protein that drives inflammation in rheumatoid arthritis, some childhood arthritis and giant cell arteritis. It became widely known during the pandemic as a treatment for severe COVID-19.
Interleukin-6 raises the body's inflammatory response. By blocking its receptor rather than the protein itself, tocilizumab stops the signal however much interleukin-6 is present.
Either an infusion into a vein every four weeks, or an injection under the skin every week or two, from a pre-filled syringe or pen. Not every biosimilar has both forms.
Rheumatoid arthritis, giant cell arteritis, childhood arthritis, the immune reaction after some cancer cell therapies and, in some markets, severe COVID-19.
A biosimilar is compared in the laboratory, in healthy volunteers using the infusion form, and in a clinical study in rheumatoid arthritis. The under-the-skin form is then linked by a further volunteer study.
The reference product is Actemra in the United States and RoActemra in Europe, from Roche. Demand surged in 2021 during the pandemic, and biosimilars followed the expiry of the main patents from 2023.
Tocilizumab is a newer biosimilar market, with three US products and four European ones. Both the infusion and the under-the-skin forms matter commercially, and only one product is interchangeable in both in the United States. India's experience was unusual: the pandemic produced an emergency permission for a domestic product in 2021, before any biosimilar was approved in the West.
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
- Todaysix tocilizumab biosimilars are approved in at least one of the seven markets.
- Nearest to marketComplarate has reached phase 3, the last trial before a filing.
- If all of them arriveThe approved count would rise from six to seven.
No published switching study for this molecule yet.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| FDA | Tofidence | Biogen MA Inc. | Sep 2023 | 761354 | Biosimilar | Approved | S001, S016 |
| FDA | Tyenne | Fresenius Kabi USA, LLC | Mar 2024 | 761275 | Biosimilar | Approved | S001, S016 |
| FDA | Avtozma | CELLTRION, Inc. | Jan 2025 | 761420 | Interchangeable | Approved | S001, S016 |
| EMA | Tyenne | Fresenius Kabi Deutschland GmbH | Sep 2023 | EMEA/H/C/005781 | Approved | S017 | |
| EMA | Tocilizumab STADA | STADA Arzneimittel AG | Jun 2024 | EMEA/H/C/005984 | Approved | S017 | |
| EMA | Avtozma | Celltrion Healthcare Hungary Kft. | Feb 2025 | EMEA/H/C/006196 | Approved | S017 | |
| EMA | Tuyory | Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) | Apr 2026 | EMEA/H/C/006416 | Approved | S017 | |
| MHRA | Avtozma | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Tofidence | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Tuyory | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Tyenne | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Tocilizumab BS CT | Celltrion Healthcare Japan | Sep 2025 | not published | Approved | S020 | |
| PMDA | Tocilizumab BS MA | Mochida Pharmaceutical | Mar 2026 | not published | Approved | S020 | |
| HC | Tyenne | Fresenius Kabi Canada LTD | Oct 2024 | DIN 02552450, 02552469, 02552477, 02552485, 02552493 | Approved | S022 | |
| HC | Avtozma | Celltrion INC. | Oct 2025 | DIN 02562022, 02562030, 02562049, 02562057, 02562065 | Approved | S022 | |
| CDSCO | Biopharma (INN only) | Biopharma Limited, Hyderabad (name as printed in the CDSCO list) | Oct 2021 | MF/BIO/21/000104 | Approved | S011 |
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 tocilizumab 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 tocilizumab programmes. Regulatory strategy consulting
Presentations and concentration
Intravenous: 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL vials at 20 mg/mL. Subcutaneous: 162 mg in 0.9 mL pre-filled syringes and pens.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Tofidence / Tocilizumab STADA BAT1806 | 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials | see SmPC | 20 mg/mL concentrate | · | · | · | · |
| Tyenne MSB11456 | 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials; 162 mg/0.9 mL SC (BLA 761449, March 2025) | see SmPC | 162 mg syringe and pen; 20 mg/mL concentrate | · | 162, 200, 400, 80 mg | · | · |
| Avtozma CT-P47 | 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials; 162 mg/0.9 mL SC (BLA 761498) | see SmPC | 162 mg syringe and pen; 20 mg/mL concentrate | 80 mg, 200 mg and 400 mg IV; 162 mg syringe and auto-injector | 162, 200, 400, 80 mg | · | · |
| Tuyory RGB-19 | · | see SmPC | 162 mg syringe and pen; 20 mg/mL concentrate | · | · | · | · |
| Indian emergency-use tocilizumab | · | · | · | · | · | 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials (20 mg/mL) | · |
| Tocilizumab BS MA | · | · | · | 80 mg, 200 mg and 400 mg IV; 162 mg syringe and auto-injector | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Bio-Thera Solutions | Tofidence / Tocilizumab STADA | ✓ | ✓ | ✓ | · | · | · | · |
| Fresenius Kabi | Tyenne | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Celltrion | Avtozma | ✓ | ✓ | ✓ | ✓ | ✓ | · | · |
| Gedeon Richter | Tuyory | · | ✓ | ✓ | · | · | · | · |
| Firm name incomplete in the CDSCO list (Hyderabad) | Indian emergency-use tocilizumab | · | · | · | · | · | ✓ | · |
| Mochida Pharmaceutical | Tocilizumab BS MA | · | · | · | ✓ | · | · | · |
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
Tofidence / Tocilizumab STADA
Tyenne
Avtozma
Tuyory
Indian emergency-use tocilizumab
Tocilizumab BS MA
In development
ClinicalTrials.gov holds three comparative trials of one tocilizumab biosimilar candidate against the reference product, run by one sponsor. None of the candidates (Complarate) has an approval yet in any of the seven markets. 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 |
|---|---|---|---|---|---|---|---|---|---|
| Complarate | Generium | Actemra | Phase 1 | Comparative PK | Completed | Apr 2022 | Jun 2022 | no approval in the seven markets | NCT06481202 |
| Complarate | Generium | Actemra | Phase 3 | Comparative efficacy | Completed | Feb 2023 | Jan 2024 | no approval in the seven markets | NCT06475508 |
| Complarate | Generium | Actemra | Phase 1 | Comparative PK | Active, not recruiting | Jun 2024 | Apr 2025 | no approval in the seven markets | NCT06488521 |
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 tocilizumab biosimilar?
Tyenne, from Fresenius Kabi, in Europe in September 2023. Tofidence, from Biogen, was approved in the United States the same month.
Do tocilizumab biosimilars come in both forms?
Two do in the United States and Europe, with both infusion and under-the-skin presentations. One is infusion only. The tables show which.
Are tocilizumab biosimilars interchangeable in the United States?
One is: Celltrion's Avtozma, designated for both forms on the day of approval.
Is there a tocilizumab biosimilar in India?
A domestic product received a restricted emergency permission for COVID-19 in 2021. No routine permission for arthritis appears in the published lists.
Which tocilizumab biosimilars are registered in the UAE?
None yet. Only Actemra is registered.
How is a tocilizumab biosimilar tested?
Laboratory comparison, a study in healthy volunteers, and a clinical comparison in rheumatoid arthritis, with a further volunteer study to support the under-the-skin form.
Work with EvySaif on tocilizumab
Tocilizumab 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 tocilizumab, 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)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) 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)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) 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 tocilizumab biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
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