Biocon Biologics Receives MHRA UK Approval for Vevzuo® and Evfraxy®, Denosumab Biosimilars

Biocon Biologics Receives MHRA UK Approval for Vevzuo® and Evfraxy®, Denosumab Biosimilars

Bengaluru, Karnataka, India, July 7, 2025 

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisations in the United Kingdom (UK) for Vevzuo® and Evfraxy®, biosimilars of Denosumab.

Vevzuo® is authorized for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Vevzuo is also authorized for the 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® is authorized for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women this significantly reduces the risk of vertebral, non-vertebral, and hip fractures. Furthermore, Evfraxy® is authorized for the 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, this significantly reduces the risk of vertebral fractures. Evfraxy® is also authorized for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

Clinical data showed that both Denosumab biosimilars have comparable safety and efficacy to the reference product^[i]. 

In Europe, the European Commission (EC) recently granted marketing authorisation for Biocon Biologics Denosumab biosimilars, allowing their commercialization in all European Union (EU) member states and the European Economic Area (EEA).

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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 5.8 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 nine 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). Website: www.bioconbiologics.com; Follow us on  X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. For FY24 Integrated Annual Report of Biocon Biologics click here

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) 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.  

Website: www.biocon.com; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. 

All other trademarks, registered or unregistered, are the property of their respective owners. 

[i] Anna Strzelecka, Grzegorz Kania, Pawan Kumar Singh, Kuldeep Kumar, Binay Kumar Thakur, Ashwani Marwah, Sudipta Basu, Nitin Madhukar Chaudhari, Sarika S Deodhar, Elena Wolff-Holz, Sandeep Nilkanth Athalye, Subramanian Loganathan. A Randomized, Double-blind, Multicenter, Parallel-arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity between Bmab-1000 and Prolia in Postmenopausal Women with Osteoporosis. Poster presented at ACR Congress 2024

1. Eastell, E. Orwoll, F. Cosman, A. Strzelecka, G. Kania, R. Plebanski, A. Mansukhbhai Ranpura, K. Kumar, B. Kumar Thakur, A. Marwah, S. Basu, N. Madhukar Chaudhari, S. S Deodhar, E. Wolff-Holz, S. Loganathan. Equivalence Trial of Proposed Denosumab Biosimilar Bmab-1000 And Reference Denosumab In Postmenopausal Osteoporosis: The Devote Study. Poster presented at WCO-IEF-ESCEO 2025