Zandoriah
Authorised
This medicine is authorised for use in the European Union
teriparatide
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Zandoriah is a medicine used for the treatment of osteoporosis (a disease that makes the bones fragile) in:
- women who have been through the menopause;
- men who have an increased risk of fractures;
- men and women who have an increased risk of fracture due to long-term treatment with glucocorticoids (a type of steroid).
Zandoriah contains the active substance teriparatide and is a biological medicine. It is a ‘biosimilar medicine’; this means that Zandoriah is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Zandoriah is Forsteo.
Zandoriah can only be obtained with a prescription. It is available as a solution for injection in pre-filled pens. It is given once daily as an injection under the skin of the thigh or belly. Patients may inject themselves once they have been appropriately trained.
Patients should take calcium and vitamin D supplements if they do not get enough from their diet. Zandoriah can be used for up to two years. The two-year course should be given only once during a patient’s lifetime.
For more information about using Zandoriah, see the package leaflet or contact your doctor or pharmacist.
Osteoporosis happens when there is not enough new bone growth to replace the bone that is naturally broken down. Gradually, the bones become less dense and more likely to break. In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall. Osteoporosis can also occur as a side effect of glucocorticoid treatment in men and women.
The active substance in Zandoriah, teriparatide, is identical to part of the human parathyroid hormone. It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells). It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.
Laboratory studies comparing Zandoriah with Forsteo have shown that the active substance in Zandoriah is highly similar to that in Forsteo in terms of structure, purity and biological activity. Studies have also shown that giving Zandoriah produces similar levels of the active substance in the body to those seen with Forsteo.
Because Zandoriah is a biosimilar medicine, the studies on the effectiveness of teriparatide carried out with Forsteo do not all need to be repeated for Zandoriah.
The safety of Zandoriah has been evaluated and, based on all the studies carried out, the side effects of the medicine are considered to be comparable to those of Forsteo.
The most common side effect with Zandoriah (which may affect more than 1 in 10 people) is pain in the arms or legs. Nausea (feeling sick), dizziness and headache may affect up to 1 in 10 people.
Zandoriah must not be used in patients who have other bone diseases such as Paget’s disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease. Zandoriah must not be used during pregnancy or breastfeeding.
For the full list of side effects and restrictions of Zandoriah, see the package leaflet.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Zandoriah has a highly similar structure, purity and biological activity to Forsteo and is distributed in the body in the same way.
All these data were considered sufficient to conclude that Zandoriah will have the same effects as Forsteo in its authorised uses.
Therefore, the Agency’s view was that, as for Forsteo, the benefits of Zandoriah outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zandoriah have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Zandoriah are continuously monitored. Suspected side effects reported with Zandoriah are carefully evaluated and any necessary action taken to protect patients.
Zandoriah received a marketing authorisation valid throughout the EU on 27 April 2026.
For information about the availability of this medicine in your country, contact your national competent authority.
Product information
27/04/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Zandoriah
- Active substance
- teriparatide
- International non-proprietary name (INN) or common name
- teriparatide
- Therapeutic area (MeSH)
- Osteoporosis
- Osteoporosis, Postmenopausal
- Anatomical therapeutic chemical (ATC) code
- H05AA02
Pharmacotherapeutic group
Calcium homeostasisTherapeutic 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.
News on Zandoriah
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