Jubereq

Opinion

EMA has issued an opinion on this medicine

denosumab

Overview

On 27 March 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Jubereq, intended for the prevention of skeletal-related events in adults with advanced malignancies involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone. The applicant for this medicinal product is Accord Healthcare S.L.U.

Jubereq will be available as a 120 mg solution for injection. The active substance of Jubereq is denosumab, a drug for the treatment of bone diseases (ATC code: M05BX04). Denosumab is a human monoclonal IgG2 antibody that targets the protein RANKL, which is essential for the formation, function and survival of osteoclasts, the cell type responsible for bone resorption. Increased osteoclast activity stimulated by RANKL plays a key role in bone destruction in patients with advanced cancer of bones.  Denosumab binds to RANKL with high affinity and specificity, preventing the interaction between RANKL and RANK. This leads to a reduction in osteoclast numbers and function, and a decrease in bone resorption in cortical and trabecular bones.

Jubereq is a biosimilar medicinal product. It is highly similar to the reference product Xgeva (denosumab), which was authorised in the EU on 13 July 2011. Data show that Jubereq has comparable quality, safety and efficacy to Xgeva (denosumab).

The full indication is:

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).

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.

Jubereq should be administered under the responsibility of a healthcare professional.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Jubereq

AdoptedReference Number: EMA/75347/2025

Product details

• Name of medicine:
  Jubereq
• 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
• EMA product number:
  EMEA/H/C/006398
• 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 applicant:
  Accord Healthcare S.L.U.
• Opinion adopted:
  27/03/2025
• Opinion status:
  Positive