Home/Biosimilar Atlas/Teriparatide/Sondelbay / Intas teriparatide

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) · Company profile
FDANot listed
EMAMar 2022authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONov 2010permitted
EDENot listed
Approved or registered in 3 of 7 markets
Connections
TeriparatidemoleculeIntas Pharmaceuticalsdeveloper3 of 7markets0trials behind it11other products, same developer11rival developers in its markets

About Sondelbay / Intas teriparatide

Intas's teriparatide was the first teriparatide biosimilar permitted anywhere, in India in November 2010, six years before Europe's first. In 2022 it reached Europe as Sondelbay through Accord, after an earlier application under the same name was withdrawn and refiled.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Sondelbay

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
An earlier application under the same name was withdrawn.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Sondelbay

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Sondelbay
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
20 micrograms/80 microlitres
Source
S023 (MHRA Products) · checked Sep 2026
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
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
Remarks
First teriparatide biosimilar permitted anywhere.
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Sondelbay / Intas teriparatide holds an approval, these are the other teriparatide biosimilars approved in that market.

MarketRivalsDevelopers (product)
EMA4CinnaGen (Zandoriah), Gedeon Richter (Terrosa / Movymia), Not stated in the EMA table (Livogiva), Strides Pharma (Kauliv)
MHRA6Dr. Reddy's Laboratories (Teriparatide Dr. Reddy's), Gedeon Richter (Terrosa / Movymia), Not stated in the MHRA list (Teriparatide Ambio Pharma), Strides Pharma (Kauliv), Sun Pharmaceutical Industries (Teriparatide Sun), Teva (Teriparatide Teva)
CDSCO3Enzene Biosciences (Enzene Biosciences teriparatide), USV (USV teriparatide), Zydus Lifesciences (Zydus teriparatide)

Same developer, other molecules

Other biosimilars in the Atlas developed by Intas Pharmaceuticals: Accofil / Filkri, Intas bevacizumab, Intas etanercept, Intas follitropin alfa, Intas peginterferon alfa-2b, Intas pertuzumab, Intas rituximab, Intas trastuzumab, Osvyrti / Jubereq, Pelgraz / Ennumo, Rexatilux / Razumab.

Chronology

Sources

All teriparatide biosimilars

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Data current to September 2026.