Ustekinumab biosimilars
An antibody for psoriasis, psoriatic arthritis and inflammatory bowel disease, with a wave of biosimilars arriving in 2024 and 2025.
About ustekinumab
Ustekinumab is an antibody that blocks two related signalling proteins, interleukin-12 and interleukin-23, which drive the inflammation in psoriasis and in Crohn's disease and ulcerative colitis.
Both proteins share a common building block, and ustekinumab binds to that. Blocking it switches off the immune pathways behind the skin plaques of psoriasis and the gut inflammation of bowel disease.
For psoriasis, an injection under the skin every twelve weeks after two starting doses. For bowel disease, one infusion into a vein to begin, then injections under the skin every eight weeks. Not every biosimilar has the infusion form.
Plaque psoriasis in adults and children, psoriatic arthritis, Crohn's disease and ulcerative colitis.
A biosimilar is compared in the laboratory, in healthy volunteers, and in a clinical study in people with psoriasis, where skin improvement can be measured within three months. The approval is then extended to the arthritis and bowel uses.
The reference product is Stelara, from Johnson & Johnson. Its European patent expired in 2024, and US launches followed settlement agreements in 2025.
Ustekinumab is the immunology wave that came after adalimumab, compressed into two years. Eight US products and more than ten European ones arrived between late 2023 and 2025, and nearly all the US ones are now interchangeable. The commercial questions are about the infusion form, which not every maker has, and about price in a suddenly crowded market. India has one domestic product, from Reliance.
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
- Todaythirteen ustekinumab biosimilars are approved in at least one of the seven markets.
- Nearest to marketGNR-068 has reached phase 3, the last trial before a filing.
- Further outBFI-751 is still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from thirteen to fifteen.
2 published switching studies with ustekinumab biosimilars, 1 of them trials with repeated switching, 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 | Wezlana | Amgen Inc. | Oct 2023 | 761285 | Interchangeable | Approved | S001, S016 |
| FDA | Selarsdi | Alvotech USA Inc. | Apr 2024 | 761343 | Interchangeable | Approved | S001, S016 |
| FDA | Pyzchiva | Samsung Bioepis Co., Ltd. | Jun 2024 | 761373 | Interchangeable | Approved | S001, S016 |
| FDA | Otulfi | Fresenius Kabi USA, LLC | Sep 2024 | 761379 | Interchangeable | Approved | S001, S016 |
| FDA | Imuldosa | Accord BioPharma Inc. | Oct 2024 | 761364 | Interchangeable | Approved | S001, S016 |
| FDA | Yesintek | Biocon Biologics Inc. | Nov 2024 | 761406 | Interchangeable | Approved | S001, S016 |
| FDA | Steqeyma | CELLTRION, Inc. | Dec 2024 | 761338 | Interchangeable | Approved | S001, S016 |
| FDA | Starjemza | Bio-Thera Solutions, Ltd. | May 2025 | 761419 | Interchangeable | Approved | S001, S016 |
| EMA | Uzpruvo | Stada Arzneimittel AG | Jan 2024 | EMEA/H/C/006101 | Approved | S017 | |
| EMA | Pyzchiva | Samsung Bioepis NL B.V. | Apr 2024 | EMEA/H/C/006183 | Approved | S017 | |
| EMA | Wezenla | Amgen Technology (Ireland) UC | Jun 2024 | EMEA/H/C/006132 | Approved | S017 | |
| EMA | Steqeyma | Celltrion Healthcare Hungary Kft. | Aug 2024 | EMEA/H/C/005918 | Approved | S017 | |
| EMA | Eksunbi | Samsung Bioepis NL B.V. | Sep 2024 | EMEA/H/C/006448 | Withdrawn | S017 | |
| EMA | Otulfi | Fresenius Kabi Deutschland GmbH | Sep 2024 | EMEA/H/C/006544 | Approved | S017 | |
| EMA | Fymskina | Formycon AG | Sep 2024 | EMEA/H/C/005805 | Approved | S017 | |
| EMA | Imuldosa | Accord Healthcare S.L.U. | Dec 2024 | EMEA/H/C/006221 | Approved | S017 | |
| EMA | Absimky | Accord Healthcare S.L.U. | Dec 2024 | EMEA/H/C/006585 | Withdrawn | S017 | |
| EMA | Yesintek | Biosimilar Collaborations Ireland Limited | Feb 2025 | EMEA/H/C/006444 | Approved | S017 | |
| EMA | Qoyvolma | Celltrion Healthcare Hungary Kft. | Jun 2025 | EMEA/H/C/006649 | Withdrawn | S017 | |
| EMA | Usymro | Gedeon Richter Plc. | Aug 2025 | EMEA/H/C/006467 | Approved | S017 | |
| EMA | Usrenty | Biosimilar Collaborations Ireland Limited | Sep 2025 | EMEA/H/C/006794 | Approved | S017 | |
| EMA | Usgena | Stada Arzneimittel AG | Nov 2025 | EMEA/H/C/006667 | Approved | S017 | |
| MHRA | Imuldosa | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Otulfi | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Pyzchiva | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Steqeyma | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Usymro | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Uzpruvo | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Wezenla | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Yesintek | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Ustekinumab BS F | Fuji Pharma | Sep 2023 | not published | Approved | S020 | |
| PMDA | Ustekinumab BS YD | Yoshindo | Dec 2024 | not published | Approved | S020 | |
| PMDA | Ustekinumab BS CT | Celltrion Healthcare Japan | Mar 2025 | not published | Approved | S020 | |
| PMDA | Ustekinumab BS Nipro | Nipro | Dec 2025 | not published | Approved | S020 | |
| HC | Jamteki | Jamp Pharma Corporation | Nov 2023 | DIN 02543036, 02543044 | Approved | S022 | |
| HC | Steqeyma | Celltrion INC. | Jul 2024 | DIN 02550245, 02550253, 02550261 | Approved | S022 | |
| HC | Pyzchiva | Samsung Bioepis CO., LTD | Aug 2024 | DIN 02550539, 02550547, 02550520 | Approved | S022 | |
| HC | Wezlana | Amgen Canada INC | Nov 2024 | DIN 02553309, 02553317 | Approved | S022 | |
| HC | Otulfi | Fresenius Kabi Canada LTD | Dec 2024 | DIN 02554283, 02554291, 02554305 | Approved | S022 | |
| HC | Yesintek | Biocon Biologics Canada INC | Oct 2025 | DIN 02562081, 02562103, 02562111 | Approved | S022 | |
| CDSCO | UstekiRel | Reliance Life Sciences Pvt Ltd | Apr 2023 | MF/BIO/23/000037 | Approved | S011 | |
| EDE | Wezenla | Amgen Technology (Ireland) Unlimited Company | Oct 2024 | not published | Registered | S018 | |
| EDE | Imuldosa | Accord Healthcare Limited, United Kingdom | May 2025 | 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 an ustekinumab 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 ustekinumab programmes. Regulatory strategy consulting
Presentations and concentration
45 mg/0.5 mL and 90 mg/mL are the subcutaneous presentations; 130 mg/26 mL (5 mg/mL) is the intravenous induction vial for Crohn's disease and ulcerative colitis. Not every biosimilar holds the intravenous presentation.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Wezlana / Wezenla ABP 654 | 45/0.5, 90/1 SC; 130/26 IV (BLA 761331) | see SmPC | 45 mg and 90 mg syringes and pens; 130 mg vial | · | 45, 90 mg | · | 45 mg and 90 mg syringes; 130 mg vial |
| Selarsdi / Uzpruvo / Usgena AVT04 | 45/0.5, 90/1 SC; 130/26 IV | see SmPC | 45 mg and 90 mg syringes; 130 mg vial | · | 45, 90 mg | · | · |
| Pyzchiva SB17 | 45/0.5, 90/1 SC; 130/26 IV (BLA 761425) | see SmPC | 45 mg and 90 mg syringes and pens; 130 mg vial | · | 45, 90 mg; 5 mg | · | · |
| Otulfi / Fymskina FYB202 | 45/0.5, 90/1 SC; 130/26 IV | see SmPC | 45 mg and 90 mg syringes and pens; 130 mg vial | · | 45, 90 mg; 5 mg | · | · |
| Imuldosa DMB-3115 | 45/0.5, 90/1 SC; 130/26 IV | see SmPC | 45 mg and 90 mg syringes; 130 mg vial | · | · | · | 45 mg/0.5 mL, 90 mg/mL; 130 mg/26 mL vial |
| Yesintek / Usrenty Bmab 1200 | 45/0.5, 90/1 SC; 130/26 IV | see SmPC | 45 mg and 90 mg syringes and pens; 130 mg vial | · | 45, 90 mg; 5 mg | · | · |
| Steqeyma CT-P43 | 45/0.5, 90/1 SC; 130/26 IV | see SmPC | 45 mg and 90 mg syringes and pens; 130 mg vial | 45 mg syringe; 130 mg IV vial (2026) | 45, 90 mg; 5 mg | · | · |
| Starjemza BAT2206 | 45/0.5, 90/1 SC; 130/26 IV | · | · | · | · | · | · |
| Usymro | · | see SmPC | 45 mg and 90 mg syringes; 130 mg vial | · | · | · | · |
| UstekiRel | · | · | · | · | · | 45 mg/0.5 mL and 90 mg/mL PFS | · |
| Ustekinumab BS F | · | · | · | 45 mg syringe; 90 mg syringe (2026) | · | · | · |
| Ustekinumab BS YD | · | · | · | 45 mg syringe | · | · | · |
| Ustekinumab BS Nipro | · | · | · | 45 mg syringe | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Amgen | Wezlana / Wezenla | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Alvotech | Selarsdi / Uzpruvo / Usgena | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Samsung Bioepis | Pyzchiva | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Formycon | Otulfi / Fymskina | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Dong-A ST and Meiji Seika | Imuldosa | ✓ | ✓ | ✓ | · | · | · | ✓ |
| Biocon Biologics | Yesintek / Usrenty | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Celltrion | Steqeyma | ✓ | ✓ | ✓ | ✓ | ✓ | · | · |
| Bio-Thera Solutions | Starjemza | ✓ | · | · | · | · | · | · |
| Gedeon Richter | Usymro | · | ✓ | ✓ | · | · | · | · |
| Reliance Life Sciences | UstekiRel | · | · | · | · | · | ✓ | · |
| Fuji Pharma | Ustekinumab BS F | · | · | · | ✓ | · | · | · |
| Yoshindo | Ustekinumab BS YD | · | · | · | ✓ | · | · | · |
| Nipro | Ustekinumab BS Nipro | · | · | · | ✓ | · | · | · |
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
Wezlana / Wezenla
Selarsdi / Uzpruvo / Usgena
Pyzchiva
Otulfi / Fymskina
Imuldosa
Yesintek / Usrenty
Steqeyma
Starjemza
Usymro
UstekiRel
Ustekinumab BS F
Ustekinumab BS YD
Ustekinumab BS Nipro
In development
ClinicalTrials.gov holds nine comparative trials of six ustekinumab biosimilar candidates against the reference product, run by six sponsors. Two of the candidates (BFI-751, GNR-068) 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 |
|---|---|---|---|---|---|---|---|---|---|
| AVT04 | Alvotech | Stelara | Phase 3 | Comparative efficacy | Completed | Jun 2021 | Dec 2021 | Selarsdi / Uzpruvo / Usgena | NCT04930042 |
| AVT04 | Alvotech | Stelara | Phase 1 | Comparative PK | Completed | May 2021 | Mar 2022 | Selarsdi / Uzpruvo / Usgena | NCT04744363 |
| ABP 654 | Amgen | Stelara | Phase 3 | Switching | Completed | Mar 2021 | Feb 2023 | Wezlana / Wezenla | NCT04761627 |
| BFI-751 | BioFactura | Stelara | Phase 1 | Comparative PK | Completed | Apr 2021 | Dec 2021 | no approval in the seven markets | NCT04843631 |
| FYB202 | Bioeq | Stelara | Phase 3 | Comparative efficacy | Completed | Nov 2020 | Jun 2021 | Otulfi / Fymskina | NCT04595409 |
| GNR-068 | Generium | Stelara | Phase 3 | Comparative efficacy | Active, not recruiting | Jul 2023 | Apr 2025 | no approval in the seven markets | NCT06488664 |
| GNR-068 | Generium | Stelara | Phase 1 | Comparative PK | Completed | Mar 2022 | Sep 2022 | no approval in the seven markets | NCT06481215 |
| SB17 | Samsung Bioepis | Stelara | Phase 1 | Comparative PK | Completed | Feb 2021 | Apr 2022 | Pyzchiva | NCT04772274 |
| SB17 | Samsung Bioepis | Stelara | Phase 3 | Comparative efficacy | Completed | Jul 2021 | Feb 2022 | Pyzchiva | NCT04967508 |
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 ustekinumab biosimilar?
Amgen's Wezlana in the United States, in October 2023, approved as interchangeable from the start. Europe's first was Uzpruvo in January 2024.
Are ustekinumab biosimilars interchangeable in the United States?
Yes, all eight. Most received the designation together in April 2025.
Do all ustekinumab biosimilars have the infusion form?
No. The infusion used to start treatment in bowel disease is held by most but not all products. The tables show which.
Is there an ustekinumab biosimilar in India?
Yes, one. Reliance's UstekiRel, permitted in 2023 for psoriasis and extended to psoriatic arthritis in 2024.
Which ustekinumab biosimilars are registered in the UAE?
Products from Amgen and Accord so far, alongside Stelara.
How is an ustekinumab biosimilar tested?
Laboratory comparison, a study in healthy volunteers, and a clinical comparison in plaque psoriasis, with the result extended to arthritis and bowel disease.
Work with EvySaif on ustekinumab
Ustekinumab 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 ustekinumab, 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)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)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) 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 ustekinumab biosimilar development?
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