Home/Biosimilar Atlas/Omalizumab/Omlyclo

Omlyclo

Omalizumab biosimilar developed by Celltrion, development code CT-P39. Reference product Xolair.

Brands by market: Omlyclo (USA, EU) · Commercial partner or holder: Celltrion · Company profile
FDAMar 2025approved
EMAMay 2024authorised
MHRALicenseddate not shown
PMDAMar 2026approved
HCDec 2024approved
CDSCONot listed
EDENot listed
Approved or registered in 5 of 7 markets
Connections
OmalizumabmoleculeCelltriondeveloper5 of 7markets0trials behind it9other products, same developer1rival developers in its markets

About Omlyclo

Omlyclo is Celltrion's omalizumab, the first omalizumab biosimilar approved anywhere outside India. Europe approved it in May 2024, Canada in December, and the United States in March 2025 as interchangeable from the start. Japan approved it in March 2026. It remains the only omalizumab biosimilar in all four markets.

Status by market

FDA

United States · Omlyclo

US Food and Drug AdministrationApproved
Brand
Omlyclo
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Mar 2025
Application or permission
761399
Licence type
351(k) interchangeable, designated Mar 2025
Reference product in the Purple Book
Xolair
Marketing status (Purple Book)
Prescription, marketed
Presentations
75 mg/0.5 mL, 150 mg/mL PFS; 300 mg/2 mL
Remarks
First omalizumab biosimilar; interchangeable on licensure.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Omlyclo

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
First EU omalizumab biosimilar.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Omlyclo

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Omlyclo
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
75 mg, 150 mg and 300 mg syringes and pens
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan · Omalizumab BS CT

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
Omalizumab BS CT
Holder or applicant
Celltrion Healthcare Japan
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2026
Indications as licensed
Bronchial asthma, seasonal allergic rhinitis, chronic idiopathic urticaria
Presentations
75 mg and 150 mg syringes and pens
Remarks
Omalizumab Biosimilar 1, the first in Japan.
Source
S020 (PMDA) · checked Sep 2026
HC

Canada · Omlyclo

Health CanadaApproved
Brand
Omlyclo
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Dec 2024
Application or permission
DIN 02553805, 02553813, 02561018, 02561026
Presentations
150, 75 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Omlyclo holds an approval, these are the other omalizumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
MHRA1Not stated in the MHRA list (Adcomfo)

Same developer, other molecules

Other biosimilars in the Atlas developed by Celltrion: Avtozma, Eydenzelt, Herzuma, Remsima / Inflectra, Steqeyma, Stoboclo / Osenvelt, Truxima / Blitzima, Vegzelma, Yuflyma.

Chronology

Sources

All omalizumab biosimilars

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Data current to September 2026.