EU application 006756
Omalizumab biosimilar developed by Applicant not yet named by EMA. Reference product Xolair.
Brands by market: Under evaluation by EMA since October 2025 · Commercial partner or holder: EU application
FDANot listed
EMAUnder review
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Not yet approved in any of the 7 markets
Connections
About EU application 006756
An application for an omalizumab biosimilar began evaluation in Europe in October 2025 and restarted in April 2026 after the applicant answered the committee's questions. The applicant will be named at opinion.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Application 006756
European Medicines Agency and European CommissionUnder reviewBrand
Application 006756
Holder or applicant
Applicant not yet named by EMA
Pathway
Centralised (Article 10(4))
Status
Under evaluation by the CHMP since Oct 2025; procedure restarted Apr 2026
Presentations
see SmPC
Remarks
Under CHMP evaluation since 2025-10-02; procedure restarted after questions 2026-04-27. Applicant not named in EMA's list.
Source
S019 (EMA) · checked Sep 2026
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAOct 2025CHMP evaluation started
Sources
S019EMA, applications for new human medicines under evaluation by the CHMP, August 2026 Primary (regulator)
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