Zandoriah (teriparatide)
- Region
- 🇪🇺 EU
- Active substance
- teriparatide
- Company
- CinnaGen Co Unipessoal LDA
- Status
- Authorised
- Therapeutic area
- Osteoporosis; Osteoporosis, Postmenopausal
- CHMP opinion
- Thu 26 Feb 2026
- EU approval
- Mon 27 Apr 2026
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006688
- ATC
- H05AA02
- Official record
- www.ema.europa.eu
Indication
Teriparatide is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Regulatory milestones
Zandoriah (teriparatide) approved in the EU
Marketing authorisation to CinnaGen Co Unipessoal LDA; Biosimilar, Additional monitoring · source
Zandoriah (teriparatide): CHMP positive opinion
CinnaGen Co Unipessoal LDA; Biosimilar, Additional monitoring · source
Same substance in other markets
- 🇪🇺 Yorvipath Authorised · Ascendis Pharma Bone Diseases A/S
- 🇪🇺 Kauliv Authorised · Strides Pharma (Cyprus) Limited
- 🇪🇺 Terrosa Authorised · Gedeon Richter Plc.
- 🇪🇺 Movymia Authorised · STADA Arzneimittel AG
- 🇪🇺 Sondelbay Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Forsteo Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Livogiva Authorised · Theramex Ireland Limited
- 🇪🇺 Teriparatide Sun Authorised · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Teriparatide Ascend Application withdrawn · Ascend GmbH
- 🇪🇺 Teriparatide Cinnagen Application withdrawn · CinnaGen Co Unipessoal LDA
- 🇪🇺 Qutavina Withdrawn · EuroGenerics Holdings B.V.
- 🇪🇺 Sondelbay Application withdrawn · Accord Healthcare S.L.U.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.