Latest news with #Denosumab
Business Standard
7 days ago
- Health
- Business Standard
Biocon Biologics receives UK MHRA marketing authorisations for Vevzuo and Evfraxy
Biocon Biologics 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. 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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Business Standard
7 days ago
- Health
- Business Standard
Biocon Biologics gets UK MHRA nod for biosimilars Vevzuo, Evfraxy
Biocon Ltd on Monday said its arm Biocon Biologics Ltd has received marketing authorisations from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for Vevzuo and Evfraxy, biosimilars of Denosumab used in the treatment of bone-related diseases. Vevzuo is authorised 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, Biocon said in a regulatory filing. It is also authorised 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. On the other hand, Evfraxy is authorised for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, the company said. In postmenopausal women, this significantly reduces the risk of vertebral, non-vertebral, and hip fractures, it added. Evfraxy is also authorised for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Biocon Biologics was recently granted marketing authorisation for Denosumab biosimilars by the European Commission (EC), allowing their commercialisation in all European Union (EU) member states and the European Economic Area (EEA), the company said.
Time of India
7 days ago
- Health
- Time of India
Biocon Biologics gets UK MHRA nod for biosimilars Vevzuo, Evfraxy
Synopsis Biocon Biologics Ltd has achieved a significant milestone. It has secured marketing authorizations in the UK for Vevzuo and Evfraxy. These are biosimilars of Denosumab. Vevzuo addresses skeletal events in adults with advanced malignancies. Evfraxy treats osteoporosis and bone loss. This approval follows a similar authorization from the European Commission. It allows commercialization across the EU and EEA.
Business Standard
7 days ago
- Health
- Business Standard
Biocon gets MHRA UK approval for marketing Denosumab biosimilars 'Vevzuo' & 'Evfraxy'
Biocon said that Biocon Biologics has received marketing authorisations from UK Medicines and Healthcare products Regulatory Agency 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. 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). Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions like diabetes, cancer, and autoimmune diseases. The companys consolidated net profit surged 154.2% to Rs 344.50 crore on a 12.8% jump in net sales to Rs 4,358.10 crore in Q4 FY25 over Q4 FY24. The scrip fell 1.29% to currently trade at Rs 375.25 on the BSE.
Business Standard
03-07-2025
- Business
- Business Standard
Biocon Biologics secures EU approval for Vevzuo and Evfraxy biosimilars
Biocon arm Biocon Biologics has received marketing authorisation from the European Commission for Vevzuo and Evfraxy – biosimilars of Denosumab used to treat bone diseases. The marketing authorisation follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on 25 April 2025, Biocon added. Vevzuo is authorised for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour (GCT) of bone. Meanwhile, Evfraxy is authorised for the treatment of osteoporosis in men with prostate cancer at increased risk of fractures or treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults. 'The approval of Vevzuo and Evfraxy in Europe underscores our strong scientific expertise and commitment to expanding patient access to essential medicines, including new therapeutic areas such as bone health. In the past 18 months, we have secured regulatory approvals for three biosimilars in Europe and two in the UK. These Denosumab biosimilars mark another significant milestone in our rapid expansion, and support for regional healthcare systems,' said Shreehas Tambe, CEO and managing director, BBL. Clinical data demonstrated that both Denosumab biosimilars exhibit comparable quality, safety, and efficacy to the reference product, the company claimed. Analysts said that the space is already crowded, and the opportunity for Biocon could be around $20 million. Nuvama Institutional Equities said that Sandoz, Samsung, and Celltrion have already received approval, with several other filers including Stada/Alvotech, Teva, Fresenius, and Shanghai Henlius and Organon awaiting entry. The European market is estimated at $1.5 billion. Assuming 75 per cent price erosion and a 5 per cent market share, the opportunity for Biocon could be $20 million, Nuvama said.
