Bone Voyage! Biocon Biologics Lands EU Approval for Denosumab Twins

Biocon Biologics Limited, a Biocon Limited subsidiary, has secured European Commission marketing approval for two Denosumab biosimilars, Vevzuo® and Evfraxy®, a major milestone in its expansion in bone health therapeutic drugs in the European Union.

 

The clearances follow a favorable experience from the European Medicines Agency's CHMP in April 2025 and allow Biocon Biologics to market these biosimilars for cancer-related bone conditions, osteoporosis, and bone giant cell tumour (GCT). The clinical trials determined that both the biosimilars are equal to the reference drug with regards to safety, quality, and efficacy.

 

Product Highlights

Vevzuo®: For the prevention of bone complications in adults with advanced cancer and the treatment of GCT of bone in adults and skeletally mature adolescents.

 

Evfraxy®: For the treatment of osteoporosis in men and postmenopausal women and glucocorticoid-induced osteoporosis in patients receiving long-term glucocorticoid therapy.

 

Market & Medical Impact

Scientific Edge

Denosumab is an RANKL-blocking monoclonal antibody that initiates protein, which activates cells responsible for bone resorption. It enhances bone mass and reduces risk of fractures by inhibiting RANKL2.

 

Sources: Financial Express, Medical Dialogues, Biocon Biologics, Business Standard, CNBC TV18