Golimumab biosimilars
A once-monthly anti-TNF antibody for arthritis and bowel disease, with the first biosimilars approved in Europe in late 2025 and the United States in 2026.
About golimumab
Golimumab is a fully human antibody that blocks TNF, like adalimumab and infliximab. Its distinguishing feature is that one injection lasts a month.
TNF drives inflammation in the joints, spine and gut. Golimumab catches it before it reaches the cells that respond, and its long stay in the body means dosing once a month.
An injection under the skin once a month, from a pre-filled syringe or pen. An infusion form exists in the United States, and one biosimilar has copied it.
Rheumatoid arthritis, psoriatic arthritis, spondylitis, ulcerative colitis and childhood arthritis.
A biosimilar is compared in the laboratory, in healthy volunteers, and in a clinical study in rheumatoid arthritis, with the result extended to the other uses.
The reference product is Simponi, from Johnson & Johnson. It is the last of the major anti-TNF antibodies to face biosimilars.
Golimumab is the newest biosimilar market in the Atlas. Nothing was approved outside India before late 2025. It is a smaller product than adalimumab, so fewer companies have entered, and there is more room for a new one. Reliance in India was first, in 2023.
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
- Todayfour golimumab biosimilars are approved in at least one of the seven markets.
- AheadNo further candidate is visible in comparative trials or under review, so the competitive set is the approved products in the register below.
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 | Immgolis | Accord BioPharma Inc. | May 2026 | 761452 | Interchangeable | Approved | S001, S016 |
| EMA | Gobivaz | Advanz Pharma Limited | Nov 2025 | EMEA/H/C/006560 | Approved | S017 | |
| EMA | Gotenfia | Stada Arzneimittel AG | Feb 2026 | EMEA/H/C/006621 | Approved | S017 | |
| MHRA | Gobivaz | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Gotenfia | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Golimumab BS F | Fuji Pharma | Sep 2025 | not published | Approved | S020 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Apr 2023 | MF/BIO/23/000038 | 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 golimumab 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 golimumab programmes. Regulatory strategy consulting
Presentations and concentration
Subcutaneous presentations are 50 mg in 0.5 mL and 100 mg in 1 mL (100 mg/mL) pre-filled syringes and pens. The intravenous presentation is 50 mg in 4 mL (12.5 mg/mL).
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Gobivaz / Gotenfia AVT05 | · | see SmPC | 50 mg and 100 mg syringes and pens; 50 mg syringe | · | · | · | · |
| Immgolis | 50 mg/0.5 mL, 100 mg/mL SC; Immgolis Intri 50 mg/4 mL IV | · | · | · | · | · | · |
| Reliance Life Sciences golimumab | · | · | · | · | · | 50 mg/0.5 mL and 100 mg/mL PFS | · |
| Golimumab BS F | · | · | · | 50 mg syringe | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Alvotech | Gobivaz / Gotenfia | · | ✓ | ✓ | · | · | · | · |
| Not stated in the Purple Book | Immgolis | ✓ | · | · | · | · | · | · |
| Reliance Life Sciences | Reliance Life Sciences golimumab | · | · | · | · | · | ✓ | · |
| Fuji Pharma | Golimumab BS F | · | · | · | ✓ | · | · | · |
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
Gobivaz / Gotenfia
Immgolis
Reliance Life Sciences golimumab
Golimumab BS F
In development
ClinicalTrials.gov holds two comparative trials of one golimumab biosimilar candidate against the reference product, run by one sponsor. Every candidate in these trials already has an approval in at least one 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 |
|---|---|---|---|---|---|---|---|---|---|
| AVT05 | Alvotech | Simponi | Phase 1 | Comparative PK | Completed | Dec 2022 | Oct 2023 | Gobivaz / Gotenfia | NCT05632211 |
| AVT05 | Alvotech | Simponi | Phase 3 | Comparative efficacy | Completed | Mar 2023 | Mar 2024 | Gobivaz / Gotenfia | NCT05842213 |
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 golimumab biosimilar?
Reliance's product in India in 2023. Outside India, Alvotech's product in Europe in November 2025, sold by Advanz and Stada.
Is there a golimumab biosimilar in the United States?
Yes, one, from Accord, approved in 2026 in both injection and infusion forms and interchangeable from the start.
Is there a golimumab biosimilar in the UAE?
Not yet. Simponi is registered.
How is a golimumab biosimilar tested?
Laboratory comparison, a study in healthy volunteers, and a clinical comparison in rheumatoid arthritis.
Is there an infusion form of the biosimilar?
In the United States, yes. Accord's product matches both the injection and the infusion form of the original.
Why did golimumab biosimilars come so late?
It is a smaller product than adalimumab or infliximab, so developers prioritised the larger molecules first.
Work with EvySaif on golimumab
Golimumab 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 golimumab, 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)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 golimumab biosimilar development?
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