Biocon Biologics, a leading global biopharmaceutical company, has achieved a significant regulatory milestone in 2025, when the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved its Denosumab biosimilars – Vevzuo and Evafraxy.

This approval marks Biocon’s strategic entry into the UK market for osteoporosis and cancer-related bone disease treatments, further strengthening its global presence in the biosimilar sector.

What Are Denosumab Biosimilars?

Denosumab is a monoclonal antibody that targets RANKL (Receptor Activator of Nuclear factor Kappa-Β Ligand), used in the treatment of:

• Osteoporosis in postmenopausal women and men at increased risk of fractures
• Bone loss due to hormone ablation in cancer
• Prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors

With patent expiries of reference brands like Prolia and Xgeva, biosimilar versions like Vevzuo (biosimilar to Prolia) and Evfraxy (biosimilar to Xgeva) are poised to offer more affordable access to these critical therapies in the UK and EU.

Why This Approval Matters in 2025

The 2025 UK biosimilar market is expanding rapidly, with a growing emphasis on affordability and access to biologic medicines. The MHRA approval of Biocon Biologics Denosumab biosimilars signals:

• Trust in Biocon’s manufacturing quality and clinical data
• Entry into a £150+ million UK market for Denosumab-related treatments
• Alignment with NHS initiatives to improve cost-effective access to biologics

According to market analysts, Denosumab biosimilars in 2025 are expected to capture over 30% of the biologics market share in bone health therapies within the UK by the end of the year.

Learn more about India’s Pharma Exports Surge 9%, Beating Global Growth Rate: Report.

Biocon Biologics Global Strategy in Biosimilars

Biocon Biologics, a subsidiary of Biocon Limited, has already made significant progress in the biosimilar industry with its products focused on oncology, immunology and metabolic diseases. With Weizhuo and Avafrexy, Biocon aims to:

• Enhance global accessibility to life-saving biosimilars
• Reduce treatment costs in developed and emerging markets
• Compete directly with global pharmaceutical giants in high-demand therapeutic areas

The Company’s acquisition of Viatris’ biosimilar business in 2023 further strengthens its global commercial capabilities, including infrastructure in North America and Europe.

Clinical Equivalence and Patient Benefits

Vevzuo and Evfraxy have undergone extensive clinical trials, demonstrating:

• Pharmacokinetic and pharmacodynamic similarity to the reference Denosumab products
• Comparable efficacy and safety profiles, especially in patients with osteoporosis and metastatic bone diseases
• Cost advantages without compromising therapeutic outcomes

This brings new hope for millions of patients in the UK and beyond who require long-term bone health management.

2025 Outlook for Denosumab Biosimilars Market

According to IQVIA and GlobalData reports:

• The global Denosumab biosimilars market is expected to reach USD 1.5 billion by 2027.
• Europe, led by the UK, Germany, and France, is projected to be the largest regional market due to high osteoporosis prevalence and biosimilar-friendly regulatory frameworks.
• NHS savings from biosimilars like Vevzuo and Evfraxy could exceed £40 million annually by 2026.

How This Impacts Patients & Healthcare Providers

• Patients benefit from reduced treatment costs, especially for chronic osteoporosis care.
• Healthcare providers can offer more treatment options with similar efficacy and safety.
• Governments and insurers save significantly through biosimilar substitution.

Conclusion

The UK approval of Vevzuo and Evfraxy is a significant milestone in Biocon Biologics journey to become a global leader in the denosumab biosimilar market.

As demand for affordable biologics grows in 2025, Biocon is well positioned to deliver value to patients, providers, and payers around the world.

FAQs