Biocon Biologics Secures EU Approval for Denosumab Biosimilars Vevzuo® and Evfraxy®, Entering Bone Health Market

Bengaluru, July 3, 2025: Biocon Limited (NSE: BIOCON, BSE: 532523) today announced a significant regulatory achievement for its subsidiary, Biocon Biologics Ltd (BBL). The European Commission (EC) has granted marketing authorisation in the European Union (EU) for BBL’s Denosumab biosimilars, Vevzuo® and Evfraxy®, marking Biocon’s entry into the high-growth bone health segment of the global biosimilars market.

Strategic Milestone for Biocon Biologics in Bone Health

This EU marketing authorisation is a crucial step for Biocon Biologics, expanding its therapeutic portfolio. Vevzuo® and Evfraxy® are biosimilars referencing Denosumab, a widely used biologic for a range of bone-related disorders.

• Vevzuo®: Approved for the prevention of skeletal-related events in adults with advanced cancers involving bone and the treatment of giant cell tumour (GCT) of bone in adults and skeletally mature adolescents. Skeletal-related events (SREs) are serious bone complications that can occur in cancer patients with bone metastases, including pathological fractures, spinal cord compression, or the need for radiation or surgery to the bone. Giant cell tumours (GCTs) of bone are typically non-cancerous but aggressive tumours that can damage bone and surrounding tissues. They are often treated with surgery, but denosumab can be used for unresectable tumours or where surgery would cause severe morbidity.
• Evfraxy®: Approved for treating osteoporosis in postmenopausal women and men at increased risk of fractures, and for bone loss due to hormone ablation or long-term glucocorticoid therapy. Osteoporosis is a condition that weakens bones, making them fragile and more prone to fractures. Denosumab is a key treatment option for postmenopausal women with osteoporosis at high risk of fractures, often used when bisphosphonates are not suitable or tolerated.

These approvals follow a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025.

Clinical Data Validates Biosimilarity

Comprehensive Phase 3 studies demonstrated that both Vevzuo® and Evfraxy® exhibit comparable safety, efficacy, and pharmacodynamics to the reference product, Prolia®. This robust clinical data reinforces their suitability as effective and safe treatment options for European patients suffering from osteoporosis, cancer-induced bone complications, or GCT.

Executive Commentary

Shreehas Tambe, CEO & MD, Biocon Biologics, stated:

“The approval of Vevzuo and Evfraxy in Europe underscores our strong scientific expertise and commitment to expanding patient access to essential medicines, including to new therapeutic areas such as bone health. In the past 18 months, we have successfully secured regulatory approvals for three biosimilars in Europe and two in the UK.”

Market Context and Epidemiology

Biocon’s entry into the bone health segment comes amid rising incidence:

(Source: Biocon press release, July 3, 2025)

About the Molecule: Denosumab

Denosumab is a human monoclonal antibody that specifically targets and binds to RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand). RANKL is a critical protein involved in the formation, function, and survival of osteoclasts, which are the cells responsible for bone resorption (breakdown). By blocking RANKL, denosumab effectively inhibits bone breakdown, leading to increased bone mass and strength. This mechanism of action makes it highly effective in treating both osteoporosis and cancer-related skeletal events.

Share Price Performance

On July 3, the shares of Biocon opened 0.26% or ₹0.95 higher at ₹369.50. It remains to be seen how the shares perform throughout today’s market session and at what price they close at the end.

About Biocon Biologics and Biocon Ltd

Biocon Biologics has commercialised nine biosimilars across 120+ countries, with a portfolio spanning diabetology, oncology, immunology, ophthalmology, and bone health. The company has 20 biosimilar assets in the pipeline and serves over 5.8 million patients globally.

Biocon Ltd, listed since 2004, is a leading innovation-driven biopharma company with strong capabilities in biosimilars, novel biologics, and complex generics. Its footprint spans India, the US, Europe, and other emerging markets.

REF: https://nsearchives.nseindia.com/corporate/Biocon2_03072025082035_PressRelease03072025.pdf

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