Latest news with #Denosumab
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Business Standard
a day ago
- 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.
Time of India
a day ago
- Business
- Time of India
Biocon biologics receives European Commission approval for Vevzuo, Evfraxy Denosumab biosimilars for bone diseases
Biocon Ltd on Thursday said its arm Biocon Biologics Ltd has been granted marketing authorisation by the European Commission for Vevzuo and Evfraxy biosimilars of Denosumab used in the treatment of different bone diseases. The marketing authorisation for the European Union (EU) follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025, Biocon Ltd said in a regulatory filing. 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. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Join new Free to Play WWII MMO War Thunder War Thunder Play Now Evfraxy is authorised for the treatment of osteoporosis in men and postmenopausal women, the treatment of bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures or the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults, the company said. "The approval of Vevzuo and Evfraxy in Europe underscores our strong scientific expertise and commitment to expanding patient access to essential medicines, including to new therapeutic areas such as bone health," Biocon Biologics CEO & Managing Director Shreehas Tambe said. Live Events Further, Tambe said, "In the past 18 months, we have successfully 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 healthcare systems in the region."
Business Standard
a day ago
- Business
- Business Standard
Biocon's biologics arm gets regulatory approval in EU for Denosumab biosimilars
Biocon said that Biocon Biologics has received the European Commission (EC) marketing authorisation in the European Union (EU) for Vevzuo and Evfraxy biosimilars of Denosumab. 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. 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. Evfraxy is authorised for the treatment of osteoporosis in men and postmenopausal women, the treatment of bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures or treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults. Clinical data showed that both Denosumab biosimilars have comparable quality, safety, and efficacy to the reference product. The marketing authorisation follows a positive opinion issued by the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025. Shreehas Tambe, CEO & managing director, Biocon Biologics, said: The approval of Vevzuo and Evfraxy in Europe underscores our strong scientific expertise and commitment to expanding patient access to essential medicines, including to new therapeutic areas such as bone health. In the past 18 months, we have successfully 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 healthcare systems in the region. 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 shed 0.20% to currently trade at Rs 367.65 on the BSE.
Business Standard
a day ago
- Health
- Business Standard
Biocon Biologics receives EU marketing authorisation for Vevzuo and Evfraxy biosimilars of Denosumab
Biocon Biologics(BBL), a fully integrated global biosimilars company and subsidiary of Biocon, today announced that the European Commission (EC) has granted marketing authorisation in the European Union (EU) for Vevzuo and Evfraxy biosimilars of Denosumab. 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. Evfraxy is authorised for the treatment of osteoporosis in men and postmenopausal women, the treatment of bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures or treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults. Clinical data showed that both Denosumab biosimilars have comparable quality, safety, and efficacy to the reference product. 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.
Business Upturn
a day ago
- Health
- Business Upturn
Biocon Biologics gets marketing authorisation from EC for Denosumab Biosimilars Vevzuo and Evfraxy
By Aman Shukla Published on July 3, 2025, 08:25 IST Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd and a leading global biosimilars company, has received marketing authorisation from the European Commission (EC) for its biosimilars Vevzuo® and Evfraxy®, both referencing Denosumab. This regulatory milestone allows the company to market the two products across the European Union (EU), marking a significant step in its journey to expand its presence in advanced biologics. Vevzuo® has been approved for the prevention of skeletal-related events in adults suffering from advanced cancers that involve bone, as well as for the treatment of giant cell tumour (GCT) of bone in adults and skeletally mature adolescents. On the other hand, Evfraxy® has been cleared for a broader range of uses in bone health, including the treatment of osteoporosis in men and postmenopausal women. It is also authorised for treating bone loss associated with hormone ablation therapy in men with prostate cancer and long-term systemic glucocorticoid therapy in adults. Both biosimilars have demonstrated comparable quality, safety, and efficacy to the reference Denosumab product based on comprehensive clinical trial data. This approval from the EC follows a positive recommendation issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
