Bemfola
Follitropin alfa biosimilar developed by Finox Biotech. Reference product Gonal-f.
Brands by market: Bemfola (EU, UAE) · Commercial partner or holder: Gedeon Richter (EU, UAE) · Company profile
FDANot listed
EMAMar 2014authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDESep 2016registered
Approved or registered in 3 of 7 markets
Connections
About Bemfola
Bemfola was developed by Finox Biotech of Switzerland and approved in Europe in March 2014, the second follitropin alfa biosimilar. Gedeon Richter acquired it and sells it in Europe and the Gulf, where it is registered in the UAE in five strengths, the only fertility biosimilar registered there.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Bemfola
European Medicines Agency and European CommissionApprovedBrand
Bemfola
Holder or applicant
Gedeon Richter Plc.
Pathway
Centralised (Article 10(4))
Approved
Mar 2014
Application or permission
EMEA/H/C/002615
Indications as licensed
Anovulation, controlled ovarian stimulation, LH/FSH deficiency, male hypogonadotropic hypogonadism
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Bemfola
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Bemfola
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 to 450 IU pens
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Bemfola
Emirates Drug EstablishmentRegisteredBrand
Bemfola
Holder or applicant
Gedeon Richter Plc., Hungary · UAE supplier Gulf Drug LLC
Pathway
Registered medical product
Registered
Sep 2016
Presentations
75, 150, 225, 300 and 450 IU pens
Source
S018 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Bemfola holds an approval, these are the other follitropin alfa biosimilars approved in that market.
Chronology
- EMAMar 2014Authorised by the European Commission as Bemfola
- EDESep 2016Registered in the UAE as Bemfola
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
Planning follitropin alfa biosimilar development?
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Talk to a biosimilar regulatory consultantData current to September 2026.