Denosumab Intas
Authorised
This medicine is authorised for use in the European Union
denosumab
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Denosumab Intas is a medicine that contains the active substance denosumab and is used to treat the following conditions:
- osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones). In women who have been through the menopause denosumab reduces the risk of fractures in the spine and elsewhere in the body, including in the hip;
- bone loss in men receiving treatment for prostate cancer that increases their risk of fractures; denosumab reduces the risk of fractures in the spine;
- bone loss in adults at increased risk of fractures who are treated long term with corticosteroid medicines given by mouth or injection.
Denosumab Intas is a biological medicine. It is a ‘biosimilar medicine’; this means that Denosumab Intas is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Denosumab Intas is Prolia. For more information on biosimilar medicines, see here.
Denosumab Intas is available as a solution for injection in prefilled syringes.
Denosumab Intas is given once every 6 months as an injection under the skin in the thigh, abdomen (belly) or back of the arm. During treatment with Denosumab Intas, the doctor should ensure that the patient is receiving calcium and vitamin D supplements. Denosumab Intas can be given by someone who has been trained in how to give injections appropriately.
The medicine can only be obtained with a prescription.
For more information about using Denosumab Intas, see the package leaflet or contact your doctor or pharmacist.
The active substance in Denosumab Intas, denosumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific structure in the body called RANKL. RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue. By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
This reduces the loss of bone and maintains bone strength, making fractures less likely to happen.
Laboratory studies comparing Denosumab Intas with Prolia have shown that the active substance in Denosumab Intas is highly similar to that in Prolia in terms of structure, purity and biological activity. Studies have also shown that giving Denosumab Intas produces similar levels of the active substance in the body to those seen with Prolia.
In addition, a study in 522 women with osteoporosis who have been through the menopause compared the effectiveness of Denosumab Intas with that of Prolia. After a year of treatment, bone mineral density (a measure of how strong the bones are) in the spine increased by around 6% in both women who received Denosumab Intas and those who received Prolia.
Because Denosumab Intas is a biosimilar medicine, the studies on the effectiveness of denosumab carried out with Prolia do not all need to be repeated for Denosumab Intas.
The safety of Denosumab Intas has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Prolia.
For the complete list of side effects and restrictions of Denosumab Intas, see the package leaflet.
The most common side effects with Denosumab Intas (which may affect more than 1 in 10 people) include pain in the arms or legs, and bone, joint and muscle pain. Uncommon side effects (which may affect up to 1 in 100 people) include cellulitis (inflammation of deep skin tissue). Rare side effects (which may affect up to 1 in 1,000 people) include hypocalcaemia (low blood calcium), hypersensitivity (allergy), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and unusual fractures of the thigh bone.
Denosumab Intas must not be used in people with hypocalcaemia (low blood calcium levels).
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Denosumab Intas has a highly similar structure, purity and biological activity to Prolia and is distributed in the body in the same way. In addition, a study has shown that Denosumab Intas and Prolia are equivalent in terms of safety and benefits in women with osteoporosis who have been through the menopause.
All these data were considered sufficient to conclude that Denosumab Intas will have the same effects as Prolia in its authorised uses. Therefore, the Agency’s view was that, as for Prolia, the benefits of Denosumab Intas outweigh the identified risks and it can be authorised for use in the EU.
The company that markets Denosumab Intas will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Denosumab Intas have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Denosumab Intas are continuously monitored. Suspected side effects reported with Denosumab Intas are carefully evaluated and any necessary action taken to protect patients.
Denosumab Intas received a marketing authorisation valid throughout the EU on 17 November 2025.
Product information
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
- Denosumab Intas
- Active substance
- denosumab
- International non-proprietary name (INN) or common name
- denosumab
- Therapeutic area (MeSH)
- Bone Resorption
- Osteoporosis
- Osteoporosis, Postmenopausal
- Anatomical therapeutic chemical (ATC) code
- M05BX04
Pharmacotherapeutic group
Drugs for treatment of bone diseasesTherapeutic indication
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.
Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.
Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
News on Denosumab Intas
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