Biocon Biologics gains EU approval for bone health therapies
Ella Day | July 4, 2025 | News story | Market Access, Medical Communications, Research and Development | Biocon Biologics, Committee for Medicinal Products for Human USE, European Commission, Evfraxy, Oncology, Orthopaedics, Osteoporosis, Vevzuo, bone health, osteoporosis, prostate cancer
Biocon Biologics has announced that the European Commission has granted marketing authorisation for its denosumab biosimilars, Vevzuo and Evfraxy, marking a significant step in expanding patient access to critical bone health treatments across Europe.
Vevzuo is approved for the prevention of skeletal complications in adults with advanced cancers involving bone, as well as for treating giant cell tumour of bone in adults and adolescents.
Evfraxy is authorised for the treatment of osteoporosis in men and postmenopausal women, as well as bone loss associated with hormone ablation in prostate cancer and long-term glucocorticoid therapy in adults.
Both biosimilars have shown comparable quality, safety and efficacy to the reference product, building on a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in April 2025.
“The approval of Vevzuo and Evfraxy underscores our commitment to expanding patient access to essential medicines and marks another key milestone in our growth across Europe,” commented Shreehas Tambe, CEO of Biocon Biologics.
Denosumab blocks RANKL, a protein essential for the formation and activity of osteoclasts, reducing bone resorption and strengthening bone mass. These new biosimilars target significant unmet needs in osteoporosis, a condition affecting an estimated 32 million Europeans 50 years or older, as well as bone complications from cancer – a major cause of morbidity.
Ella Day
4/7/25
Related Content
European Commission approves HIV prevention injection
The European Commission (EC) has granted marketing authorisation for Gilead Science’s Yeytuo (lenacapavir), the first …
Sanofi’s Sarclisa gains EU approval for multiple myeloma treatment
Sanofi has received approval from the European Commission for the use of Sarclisa (isatuximab) in …
EMA lifts temporary ban on chikungunya vaccine Ixchiq following safety review
After completing a safety review of Ixchiq – a vaccine for chikungunya – the European …
