Vedolizumab biosimilars
A gut-selective antibody for ulcerative colitis and Crohn's disease, with no biosimilar approved anywhere yet and two applications under review in Europe.
About vedolizumab
Vedolizumab is an antibody that stops immune cells entering the gut. Unlike natalizumab, which works in a similar way, it does not affect the brain, so it avoids the rare infection risk of that drug.
It blocks a molecule on immune cells that they need to enter the gut wall. With fewer immune cells arriving, the inflammation of ulcerative colitis and Crohn's disease settles.
An infusion into a vein to begin, then either further infusions every eight weeks or injections under the skin every two weeks.
Ulcerative colitis and Crohn's disease in adults.
No biosimilar has been assessed yet. A programme is likely to compare the product in the laboratory, in healthy volunteers, and in a clinical study in ulcerative colitis, with the result extended to Crohn's disease.
The reference product is Entyvio, from Takeda. Its main patents run into the late 2020s.
Vedolizumab is the next bowel disease molecule after ustekinumab and infliximab, and the first in the Atlas shown entirely as pipeline: two European applications, no approvals, no Indian or Gulf product. The market has not opened yet, and this is the stage at which companies decide their regulatory strategy.
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
- TodayNo vedolizumab biosimilar is approved yet in any of the seven markets.
- With regulators nowEU application 006853, EU application 006922 are under review. A decision usually comes within a year.
- Nearest to marketAVT16, PB016 have reached phase 3, the last trial before a filing.
- If all of them arriveThe approved count would rise from zero to four. The applications under review are anonymous in the EMA list and are probably some of the same candidates, so two is the more realistic figure.
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 |
|---|---|---|---|---|---|---|---|
| EMA | Application 006853 | Applicant not yet named by EMA | since May 2026 | EMEA/H/C/006853 | Under review | S019 | |
| EMA | Application 006922 | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/006922 | Under review | S019 |
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 vedolizumab 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 vedolizumab programmes. Regulatory strategy consulting
Presentations and concentration
Reference presentations are a 300 mg lyophilised vial for infusion and 108 mg in 0.68 mL subcutaneous syringes and pens. No biosimilar presentation has been authorised yet.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| EU application 006853 | · | see SmPC | · | · | · | · | · |
| EU application 006922 | · | see SmPC | · | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Applicant not yet named by EMA | EU application 006853 | · | review | · | · | · | · | · |
| Applicant not yet named by EMA | EU application 006922 | · | review | · | · | · | · | · |
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
EU application 006853
EU application 006922
In development
ClinicalTrials.gov holds two comparative trials of two vedolizumab biosimilar candidates against the reference product, run by two sponsors. None of the candidates (AVT16, PB016) 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 |
|---|---|---|---|---|---|---|---|---|---|
| AVT16 | Alvotech | Entyvio | Phase 3 | Comparative efficacy | Terminated | Sep 2024 | Nov 2025 | no approval in the seven markets | NCT06570772 |
| PB016 | Polpharma Biologics | Entyvio | Phase 3 | Comparative efficacy | Unknown, last active, not recruiting | Jul 2023 | Sep 2025 | no approval in the seven markets | NCT05771155 |
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
Is there a vedolizumab biosimilar approved anywhere?
No. Two applications have been under review in Europe since 2026.
Who has filed vedolizumab biosimilars in Europe?
EMA publishes the molecule and product number but not the applicant until the committee gives its opinion.
Is there a vedolizumab biosimilar in India?
No. The only Indian entries are the originator's import permissions.
When might the first vedolizumab biosimilar be approved?
A European review takes about a year if no major questions arise, so an opinion in 2027 is possible.
Why is vedolizumab attractive to developers?
It is one of the largest products in inflammatory bowel disease, has both infusion and injection forms, and avoids the safety programme that complicates natalizumab.
How would a vedolizumab biosimilar be tested?
Laboratory comparison, a volunteer study and a clinical comparison in ulcerative colitis, with the result extended to Crohn's disease.
Work with EvySaif on vedolizumab
Vedolizumab 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 vedolizumab, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S019EMA, applications for new human medicines under evaluation by the CHMP, August 2026 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)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) 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)
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