India Pharma Outlook Team | Tuesday, 02 December 2025
Biocon Biologics is moving fast after securing a major settlement with Amgen that clears the way for its Denosumab biosimilars to enter Europe and global markets.
Starting December 2, 2025, the company can commercialize both Vevzuo and Evfraxy across Europe, strengthening its position in oncology and bone-health therapies. Other settlement terms remain confidential.
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.”
Also Read: Advancing Interventional Radiology in India Through Collaboration
The timing aligns with the European Commission's approval of both products in July 2025. The company had already secured a U.S. market entry date for its Denosumab biosimilars Bosaya and Aukelso, creating a synchronized global rollout strategy.
Vevzuo is approved for preventing skeletal-related events in adults with advanced cancers involving bone and for treating giant cell tumour of bone in adults and skeletally mature adolescents. Evfraxy targets osteoporosis in postmenopausal women and men at high fracture risk, bone loss linked to hormone ablation in prostate cancer, and bone loss from long-term glucocorticoid therapy.
The need is clear. Europe counted 32 million people aged 50+ with osteoporosis in 2019, while cancer cases in the EU reached 2.74 million in 2022. With rising demand for effective bone-health treatments, Denosumab biosimilars from Biocon Biologics are set to play a bigger role in expanding access to affordable care.
