editor daily mirror
Dailymirror.news,India,December 2, 2025: Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today announced a confidential settlement agreement with Amgen Inc.
that officially paves the way for the commercial launch of its Denosumab biosimilars in Europe and other international markets.The agreement permits Biocon Biologics to begin commercializing both of its Denosumab biosimilars—Vevzuo® and Evfraxy®—in Europe starting today, December 2, 2025.
This follows a similar settlement reached in the U.S. in October.Shreehas Tambe, CEO & Managing Director of Biocon Biologics, commented on the expansion:“This settlement sets the stage for Biocon Biologics to bring our Denosumab biosimilars, Vevzuo® and Evfraxy®, to patients across Europe and key international markets. This further broadens our reach across the world in the oncology and bone health therapeutic areas, as we work with healthcare systems to expand access to affordable biologics globally.
”The European Commission (EC) granted approval for Vevzuo and Evfraxy earlier in July 2025.Molecule and Indication OverviewDenosumab is a human monoclonal antibody that works by targeting and binding to a protein called RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand). By blocking RANKL, Denosumab effectively inhibits the function of osteoclasts (cells responsible for bone resorption), thereby increasing bone mass and strength.
Approved Indications for the BiosimilarsBiocon Biologics’ two approved products cover different primary therapeutic areas:ProductPrimary IndicationsVevzuo® (denosumab biosimilar)Oncology & Bone Tumors: Prevention of skeletal-related events (fractures, radiation, surgery) in adults with advanced malignancies involving bone.
Treatment for giant cell tumour of bone (GCT).Evfraxy® (denosumab biosimilar)Bone Health: Treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer. Treatment of bone loss associated with long-term systemic glucocorticoid therapy.
Global Health ImpactThe approval addresses major global health concerns, particularly in aging populations:Osteoporosis: This condition, which weakens bones and increases fracture risk, affected an estimated 32 million individuals aged 50+ across Europe in 2019 (25.5 million of whom were women).
In the UK, one in five men over 50 is likely to break a bone due to osteoporosis.Cancer Metastasis: Nearly all types of cancer can spread to the bone, causing pain and fractures. The number of new cancer cases in the EU reached 2.74 million in 2022.Giant Cell Tumors (GCT): These locally aggressive tumors typically occur in young adults (aged 20–40) and represent 3–5% of primary bone tumors in the United States and Europe.
