Vedolizumab biosimilars
Gut-selective anti-integrin antibody for ulcerative colitis and Crohn's disease, with no biosimilar approved anywhere yet and two applications under evaluation by EMA since 2026.
About vedolizumab
Humanised IgG1 monoclonal antibody of about 147 kDa, produced in Chinese hamster ovary cells, directed against the alpha-4 beta-7 integrin heterodimer rather than the alpha-4 subunit alone.
Binds alpha-4 beta-7 integrin on gut-homing T lymphocytes and blocks its interaction with MAdCAM-1 on intestinal endothelium, preventing lymphocyte migration into inflamed gut tissue. Because it does not bind alpha-4 beta-1 it spares trafficking to the central nervous system, avoiding the progressive multifocal leukoencephalopathy risk associated with natalizumab.
Intravenous or subcutaneous; half-life about 25 days, with near-complete receptor saturation at maintenance doses. Clearance is higher with low albumin and high body weight.
300 mg intravenously at weeks 0, 2 and 6, then every eight weeks, from a 300 mg lyophilised vial; or 108 mg subcutaneously every two weeks after intravenous induction, from pre-filled syringes and pens.
- Moderately to severely active ulcerative colitis in adults
- Moderately to severely active Crohn's disease in adults
- Chronic pouchitis (EU)
Anti-vedolizumab antibodies develop in a small proportion of patients and are associated with lower concentrations. Comparative programmes will be expected to use analytical similarity, a pharmacokinetic study in healthy volunteers, and a comparative efficacy study in ulcerative colitis with clinical remission at week 6 or later as the endpoint, with extrapolation to Crohn's disease; EMA's 2026 reflection paper may allow the efficacy study to be waived where analytical and pharmacokinetic data are sufficient.
Entyvio was licensed by FDA on 20 May 2014 (BLA 125476) and authorised in the EU on 22 May 2014 (EMEA/H/C/002782), with the subcutaneous presentation added in 2020 in the EU and 2023 in the US. The composition-of-matter patents run into the late 2020s in the major markets. No biosimilar has been approved in any market in this register; two applications began evaluation at EMA in May and July 2026.
Sources: Purple Book (S016), EMA medicines data (S017), EMA list of applications under evaluation (S019), CDSCO lists (S012, S013).
Vedolizumab is the next inflammatory bowel disease molecule after ustekinumab and infliximab, and the first in this register shown entirely as pipeline: two European applications, no approvals, no Indian permission and no Gulf registration beyond the originator. For a developer it is the moment before the market opens, which is when the regulatory strategy is decided.
Sources: Entyvio summary of product characteristics (EMA) and US prescribing information (FDA).
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 |
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 | 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 | 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 | 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 | 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 | 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 | 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.
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. Biosimilar presentations will be listed once authorised.
| Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|
| EU application 006853 | · | see SmPC | · | · | · | · |
| EU application 006922 | · | see SmPC | · | · | · | · |
Sources: Purple Book (S016), PMDA list (S020), Health Canada Drug Product Database (S022), CDSCO permission lists (S011 to S014), EDE directory (S018). EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | 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
Questions
Is there a vedolizumab biosimilar approved anywhere?
No. As of September 2026 no vedolizumab biosimilar has been approved by FDA, EMA, CDSCO or registered in the UAE. Two applications have been under evaluation by EMA since May and July 2026.
Who has filed vedolizumab biosimilars with EMA?
EMA's monthly list gives the INN and product numbers (EMEA/H/C/006853 and 006922) but not the applicants; names appear only when the CHMP adopts an opinion.
Is there a vedolizumab biosimilar in India?
No. The only vedolizumab entries in CDSCO's published lists are Takeda's import permissions for Entyvio, intravenous from 2016 and subcutaneous from 2022.
When might the first vedolizumab biosimilar be authorised in the EU?
A standard centralised procedure takes about a year from start of evaluation excluding clock stops, so an application started in May 2026 could reach an opinion in 2027 if no major objections arise.
Why is vedolizumab attractive to biosimilar developers?
It is the second largest product in inflammatory bowel disease after ustekinumab, has both intravenous and subcutaneous presentations, and its gut-selective mechanism means it avoids the safety programme that complicates natalizumab.
What comparative evidence will regulators expect for vedolizumab?
Analytical comparability, pharmacokinetic equivalence in healthy volunteers, and a comparative efficacy study in ulcerative colitis, with extrapolation to Crohn's disease; EMA's 2026 reflection paper may allow the efficacy study to be waived on strong analytical and pharmacokinetic data.
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)
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