European Commission Approves Biocon Biologics' Denosumab Biosimilars for Bone Health

Advancing Bone Health: EU Approves Denosumab Biosimilars



Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., has made headlines with the recent approval from the European Commission (EC) for its Denosumab biosimilars, Vevzuo® and Evfraxy®. This pivotal decision marks significant progress in the treatment of bone health issues, particularly for patients with advanced cancer and osteoporosis.

Market Authorization Overview



The EC's authorization allows for the marketing of Vevzuo® in the European Union (EU) and is targeted at adults suffering from advanced cancers that affect bone health. This includes patients at risk of complications such as fracture, spinal cord compression, or those requiring bone surgery. Vevzuo® is also indicated for treating adults and adolescents with mature skeletal growth who present non-resectable giant cell tumours of the bone.

On the other hand, Evfraxy® is authorized for treating osteoporosis in both postmenopausal women and men at increased risk of fractures. Additionally, this biosimilar aids in managing bone loss linked to hormonal ablation in men with prostate cancer and due to prolonged use of systemic glucocorticoids in adults.

Clinical data have demonstrated that both biosimilars maintain quality, safety, and efficacy comparable to the reference product, further solidifying their potential impact on patient care in Europe.

Regulatory Journey



The approval follows a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) on April 25, 2025. Shreehas Tambe, the CEO of Biocon Biologics, highlighted the significance of this milestone, stating, "The approval of Vevzuo® and Evfraxy® in Europe underscores our strong scientific expertise and commitment to expanding patient access to essential medicines, including new therapeutic areas like bone health." He noted that in the past 18 months, Biocon Biologics successfully secured regulatory approvals for three biosimilars in Europe and two in the UK, representing an important step in their rapid regional expansion.

Understanding Denosumab



Denosumab is a human monoclonal antibody that binds to a protein called RANKL (Receptor Activator of Nuclear factor Kappa-Β Ligand). RANKL plays a crucial role in osteoclast formation, function, and survival, which are the cells responsible for bone resorption. By inhibiting RANKL, denosumab effectively reduces bone degradation, leading to increased bone mass and strength.

Complete Indications of Vevzuo® and Evfraxy®


  • - Vevzuo®:
- Prevention of bone complications (such as pathological fractures, radiation to bones, spinal cord compression, or bone surgery) in adults with advanced malignancies affecting bone.
- Treatment of adults and adolescents with mature skeletal growth presenting with non-resectable giant cell tumors of bone.
  • - Evfraxy®:
- Treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. In postmenopausal women, it significantly reduces the risk of vertebral, non-vertebral, and hip fractures.
- Treatment of bone loss due to hormonal ablation in high-risk men with prostate cancer, significantly reducing vertebral fracture risk.
- Treatment of bone loss related to prolonged systemic glucocorticoid use in adults at higher fracture risk.

Epidemiological Context



Osteoporosis is a condition that weakens bones, making them more fragile and prone to fractures. It develops gradually over several years and is often diagnosed only after a fracture occurs. In Europe, approximately 32 million individuals over 50 were estimated to have osteoporosis in 2019, with 25.5 million being women. According to the Royal Osteoporosis Society in the UK, one in five men over 50 is likely to suffer a fracture due to osteoporosis.

Additionally, nearly all cancer types can spread to the bones, leading to pain and fractures. In the EU, 2.74 million new cancer cases were recorded in 2022, highlighting the urgent need for effective treatment options.

Giant cell tumor (GCT) is a benign tumor type that frequently appears in young adults aged 20 to 40 years. It can be locally aggressive and destroy bone and surrounding tissue, constituting 3-5% of primary bone tumors in the U.S. and Europe.

About Biocon Biologics Limited



Biocon Biologics Limited is a fully integrated global biosimilars company dedicated to transforming healthcare and lives. The company serves over 5.8 million patients across more than 120 countries, ensuring affordable access to high-quality biosimilars. Biocon Biologics has commercialized nine biosimilars in key emerging and advanced markets, including the U.S., Europe, Australia, Canada, and Japan. Its robust portfolio includes 20 biosimilars across diverse therapeutic areas, including diabetes, oncology, immunology, ophthalmology, bone health, and other non-communicable diseases. Biocon is also committed to the UN’s Sustainable Development Goals (SDGs). For more information, visit www.bioconbiologics.com.

Biocon Ltd, publicly listed since 2004 (BSE: 532523, NSE: BIOCON, ISIN: INE376G01013), is a global biopharmaceutical company driven by innovation, focused on improving affordable access to complex therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases. It has developed and marketed innovative biologics, biosimilars, and active pharmaceutical ingredients (APIs) in India and several significant global markets, along with promising new assets in immunotherapy currently in development. For updates, follow Biocon on X (formerly Twitter @bioconlimited) and LinkedIn.

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