Biocon Biologics receives UK MHRA marketing authorisations for Vevzuo and Evfraxy
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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Time of India
6 days ago
- Time of India
Biocon sees GLP-1 weight-loss therapy as a future growth driver
Biocon will continue to deepen its push in the insulin business, even as the biopharmaceutical company will have GLP-1 weight-loss therapy as one of the key focus areas in its future growth strategy, Shreehas Tambe, chief executive of Biocon Biologics, told ET on Friday. Leveraging decades of experience in insulin, the Bengaluru-based company aims to gain an edge over rivals in the race for copycats of GLP-1 drugs, which are gaining popularity as an effective treatment for glucose control as well as weight management. Productivity Tool Zero to Hero in Microsoft Excel: Complete Excel guide By Metla Sudha Sekhar View Program Finance Introduction to Technical Analysis & Candlestick Theory By Dinesh Nagpal View Program Finance Financial Literacy i e Lets Crack the Billionaire Code By CA Rahul Gupta View Program Digital Marketing Digital Marketing Masterclass by Neil Patel By Neil Patel View Program Finance Technical Analysis Demystified- A Complete Guide to Trading By Kunal Patel View Program Productivity Tool Excel Essentials to Expert: Your Complete Guide By Study at home View Program Artificial Intelligence AI For Business Professionals Batch 2 By Ansh Mehra View Program Biocon has completed bioequivalence studies in India for semaglutide , a GLP-1 drug, and is progressing to Phase-III trials, which it expects to conclude by the end of calendar year 2026. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 'Subsequent regulatory approval is anticipated in CY 2027, after which we will launch the product in India through a partner,' said Tambe, who is also the managing director of the biosimilar and biologics subsidiary of Biocon. Novo Nordisk's blockbuster weight-loss drug semaglutide (branded Wegovy) will go off patent in India in March. Live Events On being asked about the disruption in the diabetes drug segment due to the inroads by GLP-1 products, Tambe said: 'The disruption (due to GLP-1) is complementary to insulin. We are bullish on both insulin and GLP-1.' 'The originators who brought GLP1s are the insulin companies, and they were able to do that because it is synergistic. Synergy not just in terms of the therapy area but also in terms of operations, touchpoints for prescribers, healthcare givers and customers,' said Tambe, who is also the company's managing director. Biocon has both biosimilar insulins and GLP-1 peptides that mimic a naturally occurring gut hormone that controls sugar levels and appetite. 'That is what differentiates us from the rest,' he said. 'Having been close to the market will give an advantage because it requires a lot of expertise as the drug is in the form of an injectable, given in a device, is a chronic treatment and hence requires a long-term relationship with patients who need to be trained on those devices,' said Tambe. 'All of these we have been able to do with our insulins in the past several years in 80-plus countries that is why we feel confident and we are developing both portfolios that are complementary to each other.' The company got US Food and Drug Administration approval for insulin aspart, its second interchangeable biosimilar insulin, deepening its presence in the US insulin market. 'The US FDA approval of Kirsty (biosimilar aspart) builds on the strong foundation established with Semglee (biosimilar insulin glargine), enabling us to offer patients the full range of affordable short- and long-acting insulin therapies,' he said. 'Insulin aspart we will enter by the end of this fiscal,' he said. The company got approval for diabetes drug liraglutide in India in June. The drug, used in treating type-2 diabetes, has already launched in the UK and the EU. 'We are working towards expeditiously launching the drug product through our commercialisation partners in India,' said Tambe. 'The biggest concern for the year ahead is external risks to the business, such as potential tariff and geopolitical headwinds. Some of these things are not in our control but that is the biggest concern for the whole industry too,' he said.
Economic Times
30-07-2025
- Economic Times
Biocon Biologics gets USFDA nod for diabetes medication
Agencies Representative image. New Delhi: Biocon Biologics on Wednesday said it has received approval from the US health regulator to market a diabetes treatment medication. The company, a unit of Biocon Ltd, has received approval from the US Food and Drug Administration (USFDA) for Kirsty as the first and only interchangeable biosimilar to NovoLog (Insulin Aspart). Kirsty is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. The medication will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use, Biocon said in a statement. The approval expands Biocon Biologics' biosimilar insulin portfolio, which also includes the interchangeable biosimilar, Semglee (Insulin Glargine-yfgn Injection). An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP). Kirsty has been available in Europe and Canada since 2022. As per the company, there are 38.4 million people with diabetes in the US, around 11.6 per cent of the total population, with nearly a quarter of them being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic, it added. According to IQVIA, sales of Insulin Aspart in the US stood around USD 1.9 billion in 2024. Shares of Biocon were trading 1.44 per cent up at Rs 395.80 apiece on the BSE.
Economic Times
23-07-2025
- Economic Times
Biocon Biologics launches product for autoimmune diseases in Australia
Biocon on Wednesday said its subsidiary Biocon Biologics has launched a product for the treatment of autoimmune diseases like rheumatoid arthritis, in the Australian market. The company has launched Nepexto, a biosimilar to the reference product Enbrel (Etanercept), in Australia, the company said in a regulatory filing. Nepexto will be promoted by Generic Health, a local partner and a leading provider of high-quality generic prescription, injectable and over-the-counter medicines, to expand access to patients in that country, it added. Etanercept is a fusion-protein that inhibits tumour necrosis factor (TNF) and is used in the treatment of autoimmune diseases like rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Since receiving EU marketing authorisation in 2020, Nepexto has earned broad adoption across Europe. Following the 2022 acquisition and vertical integration of the biosimilars business globally, Biocon Biologics is building on the solid foundation to strategically expand Nepexto into new markets worldwide and further strengthen its immunology offering, it said. Shares of Biocon were trading 1.72 per cent up at Rs 393.70 apiece on BSE.
