Human medicines European public assessment report (EPAR): Junod, denosumab, Date of authorisation: 23/06/2025, Revision: 2, Status: Authorised

Overview

Junod 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 fracture (broken bones). In women who have been through the menopause Junod reduces the risk of fractures in the spine and elsewhere in the body, including the hip; bone loss in men receiving treatment for prostate cancer that increases their risk of fracture. Junod 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. Junod contains the active substance denosumab and is a biological medicine. It is a 'biosimilar medicine'; this means that Junod is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Junod is Prolia. Expand section Collapse section How is Junod used? Junod can only be obtained with a prescription and is available as a solution for injection in 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 Junod, the doctor should ensure that the patient is receiving calcium and vitamin D supplements. Junod can be given by someone who has been trained in how to give injections appropriately. For more information about using Junod, see the package leaflet or contact your doctor or pharmacist. How does Junod work? The active substance in Junod, 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. What benefits of Junod have been shown in studies? Laboratory studies comparing Junod with Prolia have shown that the active substance in Junod is highly similar to that in Prolia in terms of structure, purity and biological activity. Studies have also shown that giving Junod produces similar levels of the active substance in the body to those seen with Prolia. In addition, a study involving 473 women with osteoporosis who have been through the menopause compared the effectiveness of Junod 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 4.9% in women who received Junod and 4.6% in those who received Prolia. Because Junod is a biosimilar medicine, the studies on the effectiveness carried out with Prolia do not all need to be repeated for Junod. What are the risks associated with Junod? For the complete list of side effects and restrictions with Junod, see the package leaflet. The safety of Junod 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 The most common side effects with Junod (which may affect more than 1 in 10 people) include pain in the arms or legs, and bone, joint and muscle pain. Uncommon or rare side effects (which may affect up to 1 in 1000 people) include cellulitis (inflammation of deep skin tissue), 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. Junod must not be used in people with hypocalcaemia (low blood calcium levels). Why is Junod authorised in the EU? The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Junod 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 Junod 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 Junod will have the same effects as Prolia in its authorised uses. Therefore, the Agency's view was that, as for Prolia, the benefits of Junod outweigh the identified risks and it can be authorised for use in the EU. What measures are being taken to ensure the safe and effective use of Junod? The company that markets Junod 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 Junod have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Junod are continuously monitored. Suspected side effects reported with Junod are carefully evaluated and any necessary action taken to protect patients. Other information about Junod Junod received a marketing authorisation valid throughout the EU on 23 June 2025. Junod : EPAR - Medicine overview Reference Number: EMA/179667/2025 English (EN) (145.11 KB - PDF) First published: 03/09/2025 View Other languages (22) български (BG) (189.49 KB - PDF) First published: 03/09/2025 View español (ES) (144.22 KB - PDF) First published: 03/09/2025 View čeština (CS) (167.47 KB - PDF) First published: 03/09/2025 View dansk (DA) (144.23 KB - PDF) First published: 03/09/2025 View Deutsch (DE) (152.21 KB - PDF) First published: 03/09/2025 View eesti (ET) (140.69 KB - PDF) First published: 03/09/2025 View ελληνικά (EL) (168.9 KB - PDF) First published: 03/09/2025 View français (FR) (145.65 KB - PDF) First published: 03/09/2025 View hrvatski (HR) (165.1 KB - PDF) First published: 03/09/2025 View italiano (IT) (143.58 KB - PDF) First published: 03/09/2025 View latviešu (LV) (172.53 KB - PDF) First published: 03/09/2025 View lietuvių (LT) (165.13 KB - PDF) First published: 03/09/2025 View magyar (HU) (165.52 KB - PDF) First published: 03/09/2025 View Malti (MT) (167.53 KB - PDF) First published: 03/09/2025 View Nederlands (NL) (145.08 KB - PDF) First published: 03/09/2025 View polski (PL) (168.69 KB - PDF) First published: 03/09/2025 View português (PT) (145.15 KB - PDF) First published: 03/09/2025 View română (RO) (162.32 KB - PDF) First published: 03/09/2025 View slovenčina (SK) (166.8 KB - PDF) First published: 03/09/2025 View slovenščina (SL) (164.2 KB - PDF) First published: 03/09/2025 View suomi (FI) (141.4 KB - PDF) First published: 03/09/2025 View svenska (SV) (154.93 KB - PDF) First published: 03/09/2025 View Junod : EPAR - Risk management plan English (EN) (795.83 KB - PDF) First published: 03/09/2025 View

Product information

Junod : EPAR - Product information English (EN) (814.06 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View Other languages (24) български (BG) (904.97 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View español (ES) (845.48 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View čeština (CS) (863.32 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View dansk (DA) (837.47 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View Deutsch (DE) (859.31 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View eesti (ET) (828.49 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View ελληνικά (EL) (895.86 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View français (FR) (875.85 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View hrvatski (HR) (915.09 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View italiano (IT) (847.09 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View latviešu (LV) (891.87 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View lietuvių (LT) (824.75 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View magyar (HU) (885.74 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View Malti (MT) (910.92 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View Nederlands (NL) (841.52 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View polski (PL) (867.05 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View português (PT) (860.54 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View română (RO) (947.93 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View slovenčina (SK) (908.27 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View slovenščina (SL) (844.07 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View suomi (FI) (918.75 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View svenska (SV) (853.9 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View Íslenska (IS) (820.59 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View norsk (NO) (816.07 KB - PDF) First published: 03/09/2025 Last updated: 20/08/2026 View Latest procedure affecting product information: VR/0000363030 19/08/2026 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). Junod : EPAR - All authorised presentations English (EN) (59.99 KB - PDF) First published: 03/09/2025 View Other languages (22) български (BG) (75.35 KB - PDF) First published: 03/09/2025 View español (ES) (56.71 KB - PDF) First published: 03/09/2025 View čeština (CS) (77.69 KB - PDF) First published: 03/09/2025 View dansk (DA) (50.75 KB - PDF) First published: 03/09/2025 View Deutsch (DE) (39.31 KB - PDF) First published: 03/09/2025 View eesti (ET) (56.19 KB - PDF) First published: 03/09/2025 View ελληνικά (EL) (44.86 KB - PDF) First published: 03/09/2025 View français (FR) (59.36 KB - PDF) First published: 03/09/2025 View hrvatski (HR) (75.81 KB - PDF) First published: 03/09/2025 View italiano (IT) (58.7 KB - PDF) First published: 03/09/2025 View latviešu (LV) (58.42 KB - PDF) First published: 03/09/2025 View lietuvių (LT) (77.47 KB - PDF) First published: 03/09/2025 View magyar (HU) (79.85 KB - PDF) First published: 03/09/2025 View Malti (MT) (46.07 KB - PDF) First published: 03/09/2025 View Nederlands (NL) (59.83 KB - PDF) First published: 03/09/2025 View polski (PL) (81 KB - PDF) First published: 03/09/2025 View português (PT) (63.75 KB - PDF) First published: 03/09/2025 View română (RO) (75.93 KB - PDF) First published: 03/09/2025 View slovenčina (SK) (78.57 KB - PDF) First published: 03/09/2025 View suomi (FI) (57.3 KB - PDF) First published: 03/09/2025 View Íslenska (IS) (60.28 KB - PDF) First published: 03/09/2025 View norsk (NO) (60.94 KB - PDF) First published: 03/09/2025 View

Product details

Name of medicine Junod 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 diseases Therapeutic indication Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Junod 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, Junod 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).

Authorisation details

EMA product number EMEA/H/C/006436 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 Gedeon Richter Plc. Gyomroi ut 19-21 1103 Budapest Hungary Opinion adopted 25/04/2025 Marketing authorisation issued 23/06/2025 Revision 2

Assessment history

Expand section Collapse section Changes since initial authorisation of medicine Junod : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (202.79 KB - PDF) First published: 05/01/2026 Last updated: 20/08/2026 View Initial marketing authorisation documents Junod : EPAR - Public assessment report Adopted Reference Number: EMA/165403/2025 English (EN) (7.17 MB - PDF) First published: 03/09/2025 View CHMP summary of positive opinion for Junod Adopted Reference Number: EMA/118084/2025 English (EN) (133.58 KB - PDF) First published: 25/04/2025 View