Enzene Biosciences teriparatide
Teriparatide biosimilar developed by Enzene Biosciences (Alkem). Reference product Forsteo (Forteo in the United States).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Enzene Biosciences
FDAnot listed
EMAnot listed
CDSCOJan 2021permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Enzene Biosciences Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2021
Application or permission
MF/BIO/21/000014; indications extended 8 December 2022
Indications as licensed
Osteoporosis in postmenopausal women; men and glucocorticoid-induced osteoporosis added December 2022
Presentations
600 micrograms/2.4 mL pen; 750 micrograms/3 mL
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJan 2021CDSCO permission granted
Sources
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