Bengaluru: Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), announced a settlement agreement with Amgen Inc. that clears the path for the commercialization of its Denosumab biosimilars in Europe and the rest of the world.
Key Announcement
- Biocon Biologics will commercialize Vevzuo® and Evfraxy® in Europe starting December 2, 2025.
- The settlement terms remain confidential.
- This follows Biocon Biologics’ earlier U.S. settlement in October, broadening its reach in oncology and bone health globally.
- The European Commission (EC) approved Vevzuo® and Evfraxy® in July 2025.
- Biocon Biologics had previously secured U.S. market entry dates for Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq).
Leadership Statement
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, said: “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 follows our settlement in the U.S. in October and 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.”
Molecule Information
- Denosumab is a human monoclonal antibody that targets RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand).
- RANKL regulates osteoclast formation and bone resorption.
- By blocking RANKL, denosumab prevents bone breakdown, increasing bone mass and strength.
Vevzuo® (Denosumab biosimilar)
- Prevention of skeletal-related events in adults with advanced malignancies involving bone.
- Treatment of giant cell tumour of bone in adults and skeletally mature adolescents where surgery is not feasible.
Evfraxy® (Denosumab biosimilar)
- Treatment of osteoporosis in postmenopausal women and men at risk of fractures.
- Reduces risk of vertebral, non-vertebral, and hip fractures.
- Treatment of bone loss in men with prostate cancer receiving hormone ablation.
- Treatment of bone loss in adults on long-term systemic glucocorticoid therapy.
Epidemiology
- Osteoporosis affects 32 million Europeans aged 50+ (2019), with 25.5 million women impacted.
- In the UK, 1 in 5 men over 50 are likely to suffer fractures due to osteoporosis.
- Cancer cases in the EU reached 2.74 million in 2022, with many spreading to bone.
- Giant Cell Tumour (GCT) occurs mainly in young adults (20–40 years), representing 3–5% of primary bone tumours in Europe and the U.S.
