Latest news with #BioconBiologicsLtd
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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
03-07-2025
- 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 Upturn
03-07-2025
- 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
BusinessToday
30-06-2025
- Health
- BusinessToday
Biocon Surpasses 100 Million Insulin Cartridges Supplied To MOH
Biocon Biologics Ltd's Malaysian arm, Biocon Sdn Bhd has crossed a major milestone by supplying over 100 million cartridges of recombinant human insulin (rh-insulin) to Malaysia's Ministry of Health since 2016, benefitting more than 345,000 diabetes patients nationwide. The insulin is produced at Biocon's state-of-the-art manufacturing facility in Johor, established with a cumulative investment of US$600 million. Recognised by the Malaysia Book of Records as the first and largest integrated insulin manufacturer in the country, the plant produces a wide range of insulins in various delivery forms. 'Every cartridge we produce at our state-of-the-art facility in Johor is a lifeline for someone living with diabetes,' said Biocon Biologics Chief Commercial Officer Susheel Umesh. Biocon Biologics' longstanding partnership with the Ministry of Health and Duopharma Marketing Sdn. Bhd. aims to advance insulin access and healthcare resilience. Leonard Ariff Abdul Shatar, Group Managing Director of Duopharma Biotech Berhad, reaffirmed this, stating the collaboration is focused on delivering affordable, high-quality insulin to Malaysians. Globally, Biocon Biologics is ranked among the top three producers of rh-insulin and Insulin Glargine, having delivered 9.2 billion doses to date. Related
Business Upturn
30-06-2025
- Business
- Business Upturn
Biocon Biologics crosses 100 million insulin cartridge deliveries in Malaysia
By Aman Shukla Published on June 30, 2025, 08:56 IST Biocon Biologics Ltd. (BBL), through its Malaysian arm Biocon Sdn. Bhd., has delivered over 100 million cartridges of recombinant human insulin (rh-insulin) to Malaysia's Ministry of Health (MoH). The company has been supplying insulin to Malaysia since 2016, supporting diabetes management efforts across the country. As part of a long-standing public-private partnership with the Malaysian government, Biocon Biologics has helped serve around 345,000 patients by making rh-insulin more accessible. The collaboration is aimed at supporting local healthcare needs through stable supply and improved access to affordable insulin therapy. The company's insulin manufacturing facility in Johor, established with a cumulative investment of $600 million since 2011, functions as a Center of Excellence (CoE) for insulin production. The facility is equipped to manufacture various types of insulin—regular, basal, and rapid-acting—in formats such as cartridges and delivery devices. The site has been acknowledged by the Malaysia Book of Records as the country's first and largest integrated insulin manufacturer. Globally, Biocon Biologics has distributed over 9.2 billion doses of rh-Insulin and Insulin Glargine to patients, as part of its wider effort to support insulin access worldwide. 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
