Ovaleap
Follitropin alfa biosimilar developed by Teva (BioGeneriX), development code XM17. Reference product Gonal-f.
Brands by market: Ovaleap (EU) · Commercial partner or holder: Theramex (current EU holder)
FDAnot listed
EMASep 2013authorised
PMDAnot listed
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Ovaleap
European Medicines Agency and European CommissionApprovedBrand
Ovaleap
Holder or applicant
Theramex Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Sep 2013
Application or permission
EMEA/H/C/002608
Indications as licensed
Anovulation, controlled ovarian stimulation, LH/FSH deficiency, male hypogonadotropic hypogonadism
Presentations
see SmPC
Note
First EU follitropin alfa biosimilar.
Source
S017
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
- EMASep 2013Authorised by the European Commission
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
Planning follitropin alfa biosimilar development?
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