Bomyntra
Authorised
This medicine is authorised for use in the European Union
denosumab
Medicine
Human
Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Bomyntra is a medicine used to prevent bone complications in adults with advanced cancer that has spread to the bone. These complications include fractures (breaks in the bone), spinal compression (pressure on the spinal cord caused by damage to the surrounding bone), or bone problems requiring radiotherapy (treatment with radiation) or surgery.
Bomyntra is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed. It is used in patients who cannot be treated by surgery or in whom surgery is likely to cause complications.
Bomyntra contains the active substance denosumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Bomyntra is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Bomyntra is Xgeva. For more information on biosimilar medicines, see here.
Bomyntra can only be obtained with a prescription. It is available as a solution for injection under the skin in the thigh, belly or upper arm.
To prevent bone complications in cancer that has spread to the bone, the medicine is given once every 4 weeks as a single injection under the skin. In patients with giant cell tumour of bone, it is injected under the skin once a week for 3 weeks, and then once every 4 weeks.
Patients should take calcium and vitamin D supplements while being treated with Bomyntra.
For more information about using Bomyntra, see the package leaflet or contact your doctor or pharmacist.
The active substance in Bomyntra, denosumab, is a monoclonal antibody which has been designed to recognise and attach to a protein called RANKL. This protein activates osteoclasts, the cells in the body that are involved in breaking down bone tissue. By attaching to RANKL and blocking it, denosumab reduces the formation and activity of the osteoclasts. This reduces the loss of bone, making fractures and other serious bone complications less likely. RANKL is also involved in activating the osteoclast-like cells in giant cell tumour of bone. Treatment with denosumab therefore prevents them from growing and breaking down bone, allowing normal bone to replace the tumour.
Laboratory studies comparing Bomyntra with Xgeva have shown that the active substance in Bomyntra is highly similar to that in Xgeva in terms of structure, purity and biological activity. Studies have also shown that giving Bomyntra produces similar levels of the active substance in the body to those seen with Xgeva.
In addition, a study compared the effectiveness of the denosumab in Bomyntra with that of another medicine containing denosumab in 533 women with osteoporosis (a disease that makes bones fragile) who have been through the menopause. After a year of treatment, bone mineral density in the spine (a measure of how strong the bones are) increased by 5.7 % in women who received Bomyntra and 5.1% in those who received the other denosumab medicine.
Because denosumab works in a similar way in osteoporosis and in the conditions Bomyntra is intended to treat, a specific study on the effectiveness of Bomyntra in these conditions is not needed.
The safety of Bomyntra 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 Xgeva.
For the complete list of side effects and restrictions of Bomyntra, see the package leaflet.
The most common side effects with Bomyntra (which may affect more than 1 in 10 people) include hypocalcaemia (low levels of calcium in the blood) and musculoskeletal pain (pain in the muscles and bones). Other common side effects (which may affect up to 1 in 10 people) include osteonecrosis in the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth and loose teeth).
Hypocalcaemia mostly occurs within the first 2 weeks of starting treatment and can be severe; however, it can be managed with calcium and vitamin D supplementation.
Bomyntra must not be used in patients with wounds from dental or mouth surgery that have not yet healed, or in people with severe, untreated hypocalcaemia.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Bomyntra has a highly similar structure, purity and biological activity to Xgeva and is distributed in the body in the same way. In addition, a study has shown that Bomyntra is as effective as another denosumab-containing medicine in women with osteoporosis. Denosumab works in a similar way in the treatment of osteoporosis and in Bomyntra’s intended uses.
All these data were considered sufficient to conclude that Bomyntra will have the same effects as Xgeva in its authorised uses. Therefore, the Agency’s view was that, as for Xgeva, the benefits of Bomyntra outweigh the identified risks and it can be authorised for use in the EU.
The company that markets Bomyntra 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 have symptoms.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bomyntra have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Bomyntra are continuously monitored. Suspected side effects reported with Bomyntra are carefully evaluated and any necessary action taken to protect patients.
Bomyntra received a marketing authorisation valid throughout the EU on 17 July 2025.
Product information
17/07/2025
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
- Bomyntra
- Active substance
- denosumab
- International non-proprietary name (INN) or common name
- denosumab
- Therapeutic area (MeSH)
- Neoplasms, Bone Tissue
- Giant Cell Tumor of Bone
- Anatomical therapeutic chemical (ATC) code
- M05BX04
Pharmacotherapeutic group
Drugs for treatment of bone diseasesTherapeutic indication
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression
or surgery to bone) in adults with advanced malignancies involving bone.
Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is
unresectable or where surgical resection is likely to result in severe morbidity.
News on Bomyntra
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