Gedeon Richter's Denosumab Biosimilar Junod® Available in Germany
Gedeon Richter Plc. has launched its denosumab biosimilar, Junod®, in Germany on December 1, 2025, for the treatment of osteoporosis and high fracture risk. Phase 3 data demonstrate therapeutic equivalence to the originator product with significant cost savings.
Gedeon Richter Plc. announced the launch of its denosumab biosimilar, Junod® (RGB-14-P), in Germany on December 1, 2025. The drug is approved for treating postmenopausal osteoporosis and bone loss associated with certain conditions. The European Commission granted marketing authorization for the biosimilar in June 2025.
Phase 3 clinical trials confirmed that Junod® is therapeutically equivalent to the reference product Prolia® (Amgen) in terms of efficacy, safety, and immunogenicity. The introduction of Junod® provides a cost-effective treatment option, potentially expanding access to effective osteoporosis care.
Osteoporosis affects millions globally, particularly postmenopausal women, significantly increasing fracture risk, causing pain, reducing quality of life, and incurring substantial healthcare costs. Despite available therapies, many patients remain undertreated.
Junod® is a human monoclonal antibody that inhibits the RANKL/RANK signaling pathway, thereby reducing osteoclast activity and bone resorption. It is administered as a subcutaneous injection of 60 mg every six months. Gedeon Richter manufactures the biosimilar at its own facilities in Europe.