EMA 发布 Bildyos（denosumab）EPAR：生物类似药，2025 年 9 月 17 日获批

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

Bildyos is a medicine 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 fractures (broken bones). In women who have been through the menopause, Bildyos reduces the risk of fractures in the spine and elsewhere in the body, including the hips;
• bone loss in men receiving treatment for prostate cancer that increases their risk of fractures. Bildyos 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.

Bildyos contains the active substance denosumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Bildyos is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Bildyos is Prolia.

Bildyos can only be obtained with a prescription and is available as a solution for injection in vials and prefilled syringes.

It 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 Bildyos, the doctor should ensure that the patient is receiving calcium and vitamin D supplements. Bildyos in prefilled syringes can be given by someone who has been trained in how to give injections appropriately.

For more information about using Bildyos, see the package leaflet or contact your doctor or pharmacist.

The active substance in Bildyos, denosumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a protein 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 Bildyos with Prolia have shown that the active substance in Bildyos is highly similar to that in Prolia in terms of structure, purity and biological activity. Studies have also shown that giving Bildyos produces similar levels of the active substance in the body to those seen with Prolia.

In addition, a study involving 514 women with osteoporosis who have been through the menopause compared the effectiveness of Bildyos with that of Prolia. After a year of treatment, bone mineral density in the spine (a measure of how strong the bones are) increased by around 6.1% in women who received Bildyos and 6.0% in those who received Prolia.

Because Bildyos is a biosimilar medicine, the studies on the effectiveness carried out with Prolia do not all need to be repeated for Bildyos.

The safety of Bildyos 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 with Bildyos, see the package leaflet.

The most common side effects with Bildyos (which may affect more than 1 in 10 people) include pain in the arms or legs, and bone, joint and muscle pain. Other side effects (which may affect up to 1 in 100 people) include cellulitis (inflammation of deep skin tissue). Hypocalcaemia (low blood calcium levels), hypersensitivity (allergic reactions), osteonecrosis in the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth and loose teeth) and unusual fractures of the thigh bone may affect up to 1 in 1,000 people taking this medicine.

Bildyos must not be used in people with hypocalcaemia.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Bildyos 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 Bildyos and Prolia are equivalent in terms of safety and effectiveness in women with osteoporosis who have been through the menopause.

All these data were considered sufficient to conclude that Bildyos will have the same effects as Prolia in its authorised uses. Therefore, the Agency’s view was that, as for Prolia, the benefits of Bildyos outweigh the identified risks and it can be authorised for use in the EU.

The company that markets Bildyos 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 Bildyos have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Bildyos are continuously monitored. Suspected side effects reported with Bildyos are carefully evaluated and any necessary action taken to protect patients.

Bildyos received a marketing authorisation valid throughout the EU on 17 September 2025. 

Product information

Latest procedure affecting product information:VR/0000382955

03/11/2026

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

Bildyos

Active substance

denosumab

International non-proprietary name (INN) or common name

denosumab

Therapeutic area (MeSH)

• Bone Resorption
• Osteoporosis, Postmenopausal
• Osteoporosis

Anatomical therapeutic chemical (ATC) code

M05BX04

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic 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. 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.

EMA product number

EMEA/H/C/006434

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Marketing authorisation holder

Sciencepharma Sp. z o.o

Ul. Chelmska 30/34
00-725 Warsaw
Poland

Opinion adopted

24/07/2025

Marketing authorisation issued

17/09/2025

Revision

5

This page was last updated on 03/11/2026