Sondelbay / Intas teriparatide
Teriparatide biosimilar developed by Intas Pharmaceuticals. Reference product Forsteo (Forteo in the United States).
Brands by market: Sondelbay (EU); brand not published by CDSCO (India) · Commercial partner or holder: Accord Healthcare (EU)
FDAnot listed
EMAMar 2022authorised
CDSCONov 2010permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Sondelbay
European Medicines Agency and European CommissionApprovedBrand
Sondelbay
Holder or applicant
Accord Healthcare S.L.U.
Pathway
Centralised (Article 10(4))
Approved
Mar 2022
Application or permission
EMEA/H/C/005827
Presentations
see SmPC
Note
An earlier application under the same name was withdrawn.
Source
S017
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Intas Biopharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Nov 2010
Application or permission
MF-893/10; BULK-892/10
Indications as licensed
Postmenopausal women with osteoporosis at high risk of fracture
Presentations
750 micrograms in 3 mL pre-filled cartridge
Note
First teriparatide biosimilar permitted anywhere.
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCONov 2010CDSCO permission granted
- EMAMar 2022Authorised by the European Commission as Sondelbay
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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