Omlyclo
Omalizumab biosimilar developed by Celltrion, development code CT-P39. Reference product Xolair.
Brands by market: Omlyclo (USA, EU) · Commercial partner or holder: Celltrion
FDAMar 2025approved
EMAMay 2024authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Omlyclo
US Food and Drug AdministrationApprovedBrand
Omlyclo
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Mar 2025
Application or permission
761399
Licence type
351(k) interchangeable, designated Mar 2025
Presentations
75 mg/0.5 mL, 150 mg/mL PFS; 300 mg/2 mL
Note
First omalizumab biosimilar; interchangeable on licensure.
Source
S001, S016
EMA
European Union · Omlyclo
European Medicines Agency and European CommissionApprovedBrand
Omlyclo
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
May 2024
Application or permission
EMEA/H/C/005958
Indications as licensed
Allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria
Presentations
see SmPC
Note
First EU omalizumab biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAMay 2024Authorised by the European Commission as Omlyclo
- FDAMar 2025Approved by FDA as Omlyclo
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)
Planning omalizumab biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.