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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) · Commercial partner or holder: Enzene Biosciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJan 2021permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
TeriparatidemoleculeEnzene Biosciencesdeveloper1 of 7markets0trials behind it5other products, same developer3rival developers in its markets

About Enzene Biosciences teriparatide

Enzene received its teriparatide permission in India in January 2021, in a pen matching the original, with the uses in men and in steroid-treated patients added in 2022.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
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 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Enzene Biosciences teriparatide holds an approval, these are the other teriparatide biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO3Intas Pharmaceuticals (Sondelbay / Intas teriparatide), USV (USV teriparatide), Zydus Lifesciences (Zydus teriparatide)

Same developer, other molecules

Other biosimilars in the Atlas developed by Enzene Biosciences: Enzene Biosciences adalimumab, Enzene Biosciences bevacizumab, Enzene Biosciences pertuzumab, Enzene Biosciences ranibizumab, Osqay / Enzene denosumab.

Chronology

Sources

All teriparatide biosimilars

Planning teriparatide biosimilar development?

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Data current to September 2026.