Biocon Biologics Ltd. (BBL), a global biosimilars company and subsidiary of Biocon Ltd., has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisations for its Denosumab biosimilars, Vevzuo® and Evfraxy®.
Vevzuo has been approved for the prevention of skeletal-related events such as pathological fractures, radiation to bone, spinal cord compression, or the need for bone surgery in adults with advanced cancers that have spread to the bone. It is also indicated for the treatment of adults and skeletally mature adolescents with unresectable giant cell tumour of bone or where surgery could result in serious complications.
Meanwhile, Evfraxy has received authorisation for the treatment of osteoporosis in postmenopausal women and men who are at increased risk of fractures. In postmenopausal women, it significantly reduces the risk of vertebral, non-vertebral, and hip fractures. Evfraxy is also approved for managing bone loss in men with prostate cancer undergoing hormone ablation therapy, significantly reducing the risk of vertebral fractures. Additionally, it can be used to treat bone loss in adult patients who are on long-term systemic glucocorticoid therapy and are at heightened risk of fractures.
Both biosimilars have demonstrated comparable safety and efficacy to the original reference product, according to clinical data. These UK approvals follow the recent marketing authorisation granted by the European Commission (EC), which allows the commercialization of Biocon Biologics Denosumab biosimilars across all European Union (EU) member states and countries in the European Economic Area (EEA).
This marks a significant milestone for Biocon Biologics as it continues to expand its footprint in global markets with high-quality, affordable biologics.
