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)
FDAAug 2023approved
EMASep 2023authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Tyruko
US Food and Drug AdministrationApprovedBrand
Tyruko
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Aug 2023
Application or permission
761322
Licence type
351(k) biosimilar, not interchangeable
Presentations
300 mg/15 mL vial
Note
First natalizumab biosimilar.
Source
S001, S016
EMA
European Union · Tyruko
European Medicines Agency and European CommissionApprovedBrand
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
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)
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