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Advancements in Bone Health: European Commission Approves Biocon Biologics' Biosimilars

In recent developments in bone health treatments, Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced the European Commission's approval of its Denosumab biosimilars, Vevzuo® and Evfraxy®, on July 3, 2025. This marks a significant milestone in the fight against bone complications related to cancer and osteoporosis.

About the New Biosimilars

Vevzuo® has been authorized for preventing skeletal-related events in adults with advanced cancer experiencing bone metastasis. Moreover, it is indicated for treating adults and adolescents with mature bone structure suffering from giant cell tumors (GCT) of bone when surgical intervention is not feasible due to severe risks.

On the other hand, Evfraxy® is specifically aimed at addressing osteoporosis in both postmenopausal women and men at risk of fractures associated with prostate cancer treatments, including those undergoing androgen deprivation therapy. Additionally, it is effective in treating bone loss in adults with prolonged systemic glucocorticoid therapy, which poses significant risks for fractures.

Clinical Data Supporting the Approval

The clinical studies underpinning the approval have demonstrated that Vevzuo® and Evfraxy® show comparable quality, safety, and efficacy to the reference drug, making them reliable options for healthcare providers and patients alike. The approval follows a favorable recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025.

Shreehas Tambe, CEO of Biocon Biologics, remarked, "The approval of Vevzuo and Evfraxy reinforces our scientific expertise and commitment to enhancing patient access to essential medications, including those for bone health. In the past 18 months, we have successfully gained regulatory approvals for three biosimilars in Europe and two in the UK, marking a significant expansion in our offerings for healthcare systems in the region."

Understanding Denosumab’s Mechanism

Denosumab is a human monoclonal antibody that targets and inhibits a protein known as RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand). RANKL plays a crucial role in the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, Denosumab effectively reduces bone degradation, leading to increased bone mass and strength—an essential factor in the management of osteoporosis and related conditions.

Therapeutic Indications of the Biosimilars

Vevzuo®

• - Prevention of bone-related disorders (e.g., pathological fractures, radiation-induced bone complications, or surgical interventions) in adults with advanced cancer and bone involvement.
• - Treatment of GCT in adults and adolescents with mature bone structure, when surgery poses a high risk of severe morbidity.

Evfraxy®

• - Treatment of osteoporosis in postmenopausal women and in men at high risk of fractures, particularly after cancer-related hormonal therapy.
• - Addressing bone loss associated with long-term glucocorticoid therapy in adults at heightened risk of fractures.

Epidemiological Context

Osteoporosis, a disease characterized by decreased bone density, increases fracture susceptibility and often goes undiagnosed until after a fracture occurs. In 2019, approximately 32 million individuals aged 50 and older across Europe were reported to have osteoporosis, with over 25.5 million being women. The Royal Osteoporosis Society estimates that one in five men over 50 is likely to suffer a fracture due to osteoporosis.

Moreover, many cancers can metastasize to bones, leading to pain and fractures. In 2022, the European Union reported 2.74 million new cancer cases.
Giant cell tumors of bone, while benign, can be locally aggressive and affect young adults between 20-40 years of age, comprising approximately 3-5% of primary bone tumors in both the US and Europe.

Who is Biocon Biologics?

Biocon Biologics Limited is a pioneering biopharmaceutical company devoted to transforming healthcare worldwide. Their commitment to developing affordable, high-quality biosimilars has benefitted over 5.8 million patients in over 120 countries. With a robust pipeline of 20 biosimilars covering fields such as diabetes, oncology, immunology, and bone health, Biocon Biologics aims to reduce the cost of biological treatments while enhancing health outcomes. Furthermore, the company prioritizes environmental and social governance (ESG) initiatives, aligning with the United Nations' Sustainable Development Goals (SDGs).

To stay updated on Biocon Biologics’ progress and innovations, visit www.bioconbiologics.com or follow them on X (formerly Twitter) @BioconBiologics and LinkedIn.

Conclusion

The approval of Vevzuo® and Evfraxy® represents not only a significant advancement in the treatment of bone health-related conditions but also highlights the ongoing innovation within the biosimilars market. As these medications become available across the EU, the impact on patients dealing with cancer-related bone issues and osteoporosis could be profound, paving the way for better health outcomes and quality of life for many.