Tyruko

Natalizumab biosimilar developed by Polpharma Biologics, development code PB006. Reference product Tysabri.

Brands by market: Tyruko (USA, EU) · Commercial partner or holder: Sandoz (USA, EU) · Company profile

FDAAug 2023approved

EMASep 2023authorised

MHRALicenseddate not shown

PMDANot listed

HCNot listed

CDSCONot listed

EDENot listed

Approved or registered in 3 of 7 markets

Connections

Natalizumabmolecule Polpharma Biologicsdeveloper 3 of 7markets 1trial behind it 0other products, same developer 0rival developers in its markets

About Tyruko

Tyruko is the only natalizumab biosimilar in the world, developed by Polpharma Biologics and sold by Sandoz. The United States approved it in August 2023 and Europe a month later. It is prescribed under the same virus testing and monitoring programme as the original, and its launch depended on a companion blood test being available.

Status by market

FDA

United States · Tyruko

US Food and Drug AdministrationApproved

Brand

Tyruko

Holder or applicant

Sandoz Inc.

Pathway

351(k)

Approved

Aug 2023

Application or permission

761322

Licence type

351(k) biosimilar, not interchangeable

Reference product in the Purple Book

Tysabri

Marketing status (Purple Book)

Prescription, marketed

Presentations

300 mg/15 mL vial

Remarks

First natalizumab biosimilar.

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union · Tyruko

European Medicines Agency and European CommissionApproved

Brand

Tyruko

Holder or applicant

Sandoz GmbH

Pathway

Centralised (Article 10(4))

Approved

Sep 2023

Application or permission

EMEA/H/C/005752

Indications as licensed

Relapsing remitting multiple sclerosis

Presentations

see SmPC

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Tyruko

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Tyruko

Holder or applicant

Not shown in the MHRA substance list

Pathway

UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)

Approved

not published

Presentations

300 mg vial

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Tyruko by development code, brand or developer. Registry data, sponsor-entered.

Candidate	Developer or sponsor	Reference product	Phase	Design	Registry status	Started	Primary completion	Registry record
PB006	Polpharma Biologics	Tysabri	Phase 3	Comparative efficacy	Completed	Oct 2019	Aug 2021	NCT04115488

Chronology

FDAAug 2023Approved by FDA as Tyruko
EMASep 2023Authorised by the European Commission as Tyruko

Sources

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)

All natalizumab biosimilars

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Data current to September 2026.