Biocon Biologics Secures Market Entry Date For Denosumab Biosimilars In Europe And Rest Of The World

Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. today announced a settlement agreement with Amgen Inc. that clears the path for the commercialization of its Denosumab biosimilars in Europe and the rest of the world.

The agreement allows Biocon Biologics to commercialize both its Denosumab biosimilars (Vevzuo and Evfraxy) in Europe starting December 2, 2025. The other terms of the settlement remain confidential.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, “This settlement sets the stage for Biocon Biologics to bring our Denosumab biosimilars, Vevzuo and Evfraxy, to patients across Europe and key international markets. This follows our settlement in the U.S. in October and further broadens our reach across the world in the oncology and bone health therapeutic areas, as we work with healthcare systems to expand access to affordable biologics globally.”

The European Commission (EC) had approved Vevzuo and Evfraxy in July 2025.

Biocon Biologics had secured a market entry date for its Denosumab biosimilars Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) for the United States previously.

Molecule Information:
Denosumab is a human monoclonal antibody that targets and binds 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, which are the cells responsible for bone resorption. By blocking RANKL, denosumab effectively inhibits the breakdown of bone, leading to increased bone mass and strength.

Full indications:
Vevzuo (denosumab biosimilar)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.

Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Evfraxy (denosumab biosimilar)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral, and hip fractures.

Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.

Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

Epidemiology:
Osteoporosis is a health condition that weakens bones, making them fragile and more likely to break. It develops slowly over several years and is often only diagnosed when a fall or sudden impact causes a bone to fracture.^[1]

Across Europe, 32 million individuals aged 50+ were estimated to have osteoporosis in 2019, 25.5 million of which were women.^[2]

According to the Royal Osteoporosis Society in the UK, one in five men over the age of 50 are likely to break a bone because of osteoporosis.^[3]

Nearly all types of cancer can spread to the bone and cause pain and fractures. The number of new cancer cases in the EU reached 2.74 million in 2022.^[4]

Giant cell tumour (GCT) is a type of benign (noncancerous) tumour that typically occurs in young adults between the ages of 20 and 40.^[v] They can be locally aggressive, meaning that they can grow quickly and destroy surrounding bone and soft tissue.^[vi] GCTs represent 3–5% of primary bone tumours in the United States and Europe.^[vii]

About Biocon Biologics Limited:
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve over 6.0 million patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes.

Biocon Biologics has commercialized 10 biosimilars from its portfolio which are addressing the patients’ needs in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). The meaningful progress on ESG parameters has been recognized with the Company’s inclusion in the S&P Global Sustainability Yearbook in 2025. For more information, visit www.bioconbiologics.com.

Biocon Limited
Biocon Limited, publicly listed in 2004 is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

For more information, visit www.biocon.com.

^[1] https://www.nhsinform.scot/illnesses-and-conditions/muscle-bone-and-joints/conditions-that-can-affect-multiple-parts-of-the-body/osteoporosis/#:~:text=Osteoporosis%20is%20a%20condition%20where,bone%20to%20fracture%20or%20break.

^[2] https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures#:~:text=Across%20Europe%20in%202019%20(European,aged%20%2B50)%20%5B7%5D

^[3] https://theros.org.uk/information-and-support/osteoporosis/osteoporosis-in-men/

^[4] https://ecis.jrc.ec.europa.eu/sites/default/files/2024-01/jrc_CancerEstimates2022_factsheet.pdf

^[v] https://orthoinfo.aaos.org/en/diseases–conditions/giant-cell-tumor-of-bone/

^[vi] https://www.bcrt.org.uk/information/information-by-type/giant-cell-tumor/

^[vii] https://www.sciencedirect.com/science/article/pii/S2405844024069214