Natalizumab biosimilars
An antibody for relapsing multiple sclerosis, with a single biosimilar, Tyruko, approved in the United States and Europe in 2023.
About natalizumab
Natalizumab is an antibody that stops immune cells crossing from the blood into the brain and spinal cord. It is one of the most effective treatments for relapsing multiple sclerosis, and in the United States it is also used in Crohn's disease.
It blocks a molecule on the surface of immune cells that they need to stick to blood vessel walls and cross into tissue. With the crossing blocked, the attacks on nerve fibres that cause relapses become rare.
An infusion into a vein every four weeks, under a monitoring programme, because the same action carries a rare risk of a serious brain infection.
Relapsing forms of multiple sclerosis and, in the United States, Crohn's disease.
Immune reactions to natalizumab are more common than with most biologics and can cause loss of effect, so comparing them is central. A clinical comparison is done in people with multiple sclerosis by counting new lesions on brain scans over six months.
The reference product is Tysabri, from Biogen. It was briefly withdrawn soon after its launch because of the brain infection risk and returned under a monitoring programme that still applies today.
Natalizumab shows a biosimilar entering a market defined by a safety programme rather than by price. The biosimilar must fit the same monitoring as the original, and its launch depended on a companion blood test. One developer has done it. There is no Indian or Gulf biosimilar.
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
- Todayone natalizumab biosimilar is 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 | Tyruko | Sandoz Inc. | Aug 2023 | 761322 | Biosimilar | Approved | S001, S016 |
| EMA | Tyruko | Sandoz GmbH | Sep 2023 | EMEA/H/C/005752 | Approved | S017 | |
| MHRA | Tyruko | Not shown in the MHRA substance list | not shown | not published | Approved | S023 |
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 natalizumab 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 natalizumab programmes. Regulatory strategy consulting
Presentations and concentration
A single biosimilar presentation, 300 mg in 15 mL (20 mg/mL) concentrate for infusion. The 150 mg subcutaneous syringe exists only for the reference product.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Tyruko PB006 | 300 mg/15 mL vial | see SmPC | 300 mg vial | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Polpharma Biologics | Tyruko | ✓ | ✓ | ✓ | · | · | · | · |
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
In development
ClinicalTrials.gov holds one comparative trial of one natalizumab 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 |
|---|---|---|---|---|---|---|---|---|---|
| PB006 | Polpharma Biologics | Tysabri | Phase 3 | Comparative efficacy | Completed | Oct 2019 | Aug 2021 | Tyruko | NCT04115488 |
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 is the natalizumab biosimilar?
Tyruko, developed by Polpharma and sold by Sandoz, approved in the United States in August 2023 and in Europe a month later.
Is Tyruko interchangeable in the United States?
No.
Is there a natalizumab biosimilar in India or the UAE?
No. India's only entry is the originator's import permission, and only Tysabri is registered in the UAE.
Does the biosimilar carry the same safety programme?
Yes. It is prescribed under the same virus testing and monitoring as Tysabri in both the United States and Europe.
How is a natalizumab biosimilar tested?
Laboratory comparison, a study of how the drug behaves in the body, comparison of immune reactions, and a clinical study counting new lesions on brain scans in people with multiple sclerosis.
Why is there only one natalizumab biosimilar?
The safety programme, the monitoring blood test and the clinical study make it a demanding programme for a market smaller than the anti-TNF antibodies.
Work with EvySaif on natalizumab
Natalizumab 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 natalizumab, 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)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 natalizumab biosimilar development?
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