UK's MHRA grants approval for Biocon Biologics' biosimilars Vevzuo and Evfraxy
In a significant development, Biocon Biologics, an Indian biopharmaceutical company, has secured marketing authorization from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its Denosumab biosimilars, Vevzuo and Evfraxy. The announcement was made on July 7, 2025.
Vevzuo, one of the approved biosimilars, is intended for the prevention of bone complications (skeletal-related events) in adults with advanced cancer involving bone, and for the treatment of adults and skeletally mature adolescents with giant cell tumour (GCT) of bone. The biosimilar offers benefits such as helping prevent fractures and other bone complications in patients with bone metastases from cancers, and providing treatment options for rare giant cell tumor cases in mature adolescents and adults.
Evfraxy, another approved biosimilar, is authorised for the treatment of osteoporosis in men and postmenopausal women, as well as for the treatment of bone loss linked to hormone ablation in men with prostate cancer who are at increased risk of fractures, and for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults. Evfraxy reduces the risk of vertebral, non-vertebral, and hip fractures in osteoporosis patients, addresses bone density loss and fracture risk in patients undergoing hormone ablation therapy for prostate cancer, and provides a therapeutic solution for glucocorticoid-induced osteoporosis.
Both biosimilars have demonstrated clinical equivalence in terms of safety, efficacy, and quality to the original Denosumab product. Their approvals represent an important step in expanding patient access to treatment for bone diseases in Europe and the UK. They support healthcare systems by providing cost-effective alternatives for managing bone complications related to cancer and osteoporosis.
It is worth noting that this development comes amidst a flat stock market, trading with caution ahead of US tariff calls and Q1 earnings. However, the approvals of Vevzuo and Evfraxy are expected to have a positive impact on Biocon Biologics' growth trajectory and patient care in the European Union and the UK.
[1] Biocon Biologics. (2025). Press Release: Biocon Biologics' Denosumab Biosimilars Vevzuo and Evfraxy Receive European Commission and UK MHRA Approvals. [Online]. Available: https://www.bioconbiologics.com/news/evfraxy-vevzuo-approvals
[2] European Commission. (2025). Press Release: European Commission Grants Marketing Authorisation for Denosumab Biosimilar Evfraxy. [Online]. Available: https://ec.europa.eu/commission/presscorner/detail/en/IP_25_2533
[3] UK MHRA. (2025). Press Release: MHRA Grants Marketing Authorisation for Denosumab Biosimilar Evfraxy. [Online]. Available: https://www.gov.uk/government/news/mhra-grants-marketing-authorisation-for-denosumab-biosimilar-evfraxy
[4] European Commission. (2025). Press Release: European Commission Grants Marketing Authorisation for Denosumab Biosimilar Vevzuo. [Online]. Available: https://ec.europa.eu/commission/presscorner/detail/en/IP_25_2532
[5] UK MHRA. (2025). Press Release: MHRA Grants Marketing Authorisation for Denosumab Biosimilar Vevzuo. [Online]. Available: https://www.gov.uk/government/news/mhra-grants-marketing-authorisation-for-denosumab-biosimilar-vevzuo
- The securing of marketing authorization for Biocon Biologics' Denosumab biosimilars, Vevzuo and Evfraxy, by both the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) signifies a crucial advancement in the realm of health-and-wellness, offering new therapies-and-treatments for bone diseases.
- The arrival of Vevzuo, a biosimilar aimed at preventing bone complications in advanced cancer patients and adults with giant cell tumor (GCT) of bone, adds to the science of medical-conditions treatment and provides a cost-effective alternative in managing bone complications related to cancer.
- Similarly, Evfraxy, another approved biosimilar, offers benefits for patients suffering from osteoporosis and bone loss associated with hormone ablation in men with prostate cancer or long-term systemic glucocorticoid therapy, helping reduce the risk of bone fractures and mitigate glucocorticoid-induced osteoporosis.
- As both biosimilars have demonstrated clinical equivalence with the original Denosumab product, they serve to increase patient access to treatment for bone diseases in Europe and the UK, aligning with the goals of the business and live markets.
- In the broader context of stock market fluctuations and economic factors, such as US tariff calls and Q1 earnings, the approvals of Vevzuo and Evfraxy are expected to have a positive impact on Biocon Biologics' growth trajectory and maintain a focus on patient care in the European Union and the UK.
