#India #Bengaluru #Denosumab #Biosimilars #Biocon Biologics

Significant Advancement in Bone Health

In a major leap for bone health treatment, Biocon Biologics Ltd. (BBL), a fully integrated global biosimilar company and a subsidiary of Biocon Ltd., has received approval from the European Commission for its Denosumab biosimilars, Vevzuo® and Evfraxy®. This marks a pivotal moment in addressing bone-related health issues, particularly among patients dealing with advanced cancer and osteoporosis.

Details of the Approval

The European Commission granted market authorization for Vevzuo® for the prevention of skeletal-related events in adults with advanced malignancies involving bone, as well as for adults and skeletally mature adolescents with unresectable giant cell tumors of the bone. Meanwhile, Evfraxy® was approved for the treatment of osteoporosis in men and postmenopausal women, targeting individuals with high fracture risks associated with hormonal therapy and systemic corticosteroid usage.

Clinical data confirms these biosimilars’ quality, safety, and efficacy are comparable to the reference product, further solidifying Biocon Biologics’ commitment to improving the accessibility of essential medicines in new therapeutic areas like bone health. This follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on April 25, 2025.

Insights from Biocon Biologics

Shreehas Tambe, CEO and Managing Director of Biocon Biologics, stated, "The approval of Vevzuo and Evfraxy in Europe highlights our scientific expertise and dedication to enhancing patient access to vital medications. In the last 18 months, we achieved three successful biosimilar approvals in Europe and two in the UK. The introduction of Denosumab biosimilars marks a significant milestone in our expansion efforts and reinforces the health systems in the region."

Understanding Denosumab

Denosumab is a human monoclonal antibody that primarily targets 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 inhibiting RANKL, Denosumab effectively suppresses bone degradation, leading to increased bone mass and strength.

Approved Indications

• - Vevzuo®:

- Prevention of skeletal-related events (e.g., pathological fractures, radiation to bone, spinal cord compression, or surgery to bone) in adults with advanced malignancies related to bones.
- Treatment of adults and skeletally mature adolescents with unresectable giant cell tumors of the bone, where surgical removal could cause severe complications.

• - Evfraxy®:

- Treatment of osteoporosis in postmenopausal women and men at high risk of fractures. Denosumab significantly reduces the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women.
- Treatment of bone loss associated with hormonal ablation in men with prostate cancer, thereby mitigating the risk of vertebral fractures.
- Treatment of bone loss linked to long-term systemic glucocorticoid therapy in adults with heightened fracture risks.

Osteoporosis and its Impact

Osteoporosis is a condition that significantly weakens bones, making them brittle and increasing fracture risks. It often develops slowly over the years, commonly diagnosed only after a fracture occurs, often from a fall or sudden strain. In Europe, approximately 32 million people aged 50 and over were diagnosed with osteoporosis in 2019, which included 25.5 million women. The Royal Osteoporosis Society estimates that one in five men over 50 is likely to experience a fracture due to this disease.

Moreover, virtually all cancer types can metastasize to bones, causing pain and fractures. In 2022, the EU recorded 2.74 million new cancer cases. Giant cell tumors (GCT) of bone, benign tumors typically occurring in young adults aged 20 to 40, can be locally aggressive, signifying the urgent need for effective treatments.

About Biocon Biologics

Biocon Biologics Limited, as a subsidiary of Biocon Limited, is uniquely positioned as a fully integrated global biosimilars company. Its mission is to enhance healthcare and the lives of patients significantly. The company leverages its broad capabilities from lab to market, delivering affordable access to high-quality biosimilars for over 5.8 million patients in more than 120 countries. Biocon Biologics is dedicated to utilizing state-of-the-art scientific knowledge, innovative technology platforms, global manufacturing capacity, and world-class quality systems to reduce the costs of biological therapies while achieving better treatment outcomes.

Having already commercialized nine biosimilars within its portfolio, Biocon Biologics meets substantial medical needs in critical emerging and industrial markets such as the USA, Europe, Australia, Canada, and Japan. The company is actively developing a pipeline of 20 biosimilar products across multiple therapeutic areas, establishing itself as a leader in the biopharmaceutical arena.

To learn more about Biocon Biologics, visit www.bioconbiologics.com and follow them on X (formerly Twitter) @BioconBiologics and on LinkedIn. To view Biocon Limited's integrated annual report for 2023/24, click here.