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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 company’s 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.
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.
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.
The marketing authorisation follows a positive opinion issued by the European Medicines Agency’s 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.”
The scrip shed 0.20% to currently trade at Rs 367.65 on the BSE.
Oil & gas shares jumped after declining in the past trading session.
At 10:25 IST, the barometer index, the S&P BSE Sensex advanced 278.10 points or 0.33% to 83,687.79. The Nifty 50 index jumped 107.55 points or 0.43% to 25,561.55.
In the broader market, the S&P BSE Mid-Cap index rose 0.43% and the S&P BSE Small-Cap index jumped 0.44%.
The market breadth was positive. On the BSE 2,102 shares rose and 1,406 shares fell. A total of 209 shares were unchanged.
New Listing:
Shares of Indogulf Cropsciences were currently trading at Rs 109.50 at 10:27 IST on the BSE, representing a discount of 1.35% compared with the issue price of Rs 111.
The scrip was listed at 111, matching the initial public offer (IPO) price.
So far, the stock has hit a high of Rs 112.60 and a low of Rs 105.45. On the BSE, over 4.45 lakh shares of the company were traded in the counter so far.
Buzzing Index:
The Nifty Oil & Gas index advanced 0.70% to 11,921.55. The index declined 0.17% in the past trading session.
Oil India (up 2.24%), Oil & Natural Gas Corpn (up 1.29%), GAIL (India) (up 1.18%), Gujarat State Petronet (up 1.06%), Gujarat Gas (up 0.92%), Bharat Petroleum Corporation (up 0.6%), Hindustan Petroleum Corporation (up 0.4%), Adani Total Gas (up 0.35%), Reliance Industries (up 0.31%) and Mahanagar Gas (up 0.24%) surged.
Stocks in Spotlight:
Biocon rose 0.42%. The company said that Biocon Biologics has received the European Commission (EC) marketing authorisation in the European Union (EU) for Vevzuo and Evfraxy biosimilars of Denosumab.
Rail Vikas Nigam added 0.32%. The company said that its board has approved the appointment of Chandan Kumar Verma as chief financial officer (CFO) with effect from 2 July 2025.
Biocon Ltd is up for a fifth straight session today. The stock is quoting at Rs 372.5, up 1.07% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.26% on the day, quoting at 25518.4. The Sensex is at 83618.54, up 0.25%. Biocon Ltd has gained around 10.73% in last one month.
Meanwhile, Nifty Pharma index of which Biocon Ltd is a constituent, has gained around 3.84% in last one month and is currently quoting at 22110.8, up 0.37% on the day. The volume in the stock stood at 26.19 lakh shares today, compared to the daily average of 65 lakh shares in last one month.
The benchmark July futures contract for the stock is quoting at Rs 374.3, up 1.3% on the day. Biocon Ltd is up 3.1% in last one year as compared to a 5% jump in NIFTY and a 9.9% jump in the Nifty Pharma index.
The PE of the stock is 0 based on TTM earnings ending March 25.