Biocon Biologics, a subsidiary of Biocon, has received marketing authorisation from the European Commission for two biosimilar drugs—Vevzuo and Evfraxy, both versions of Denosumab. This approval allows the company to market these products across the European UnionEuropean Union.
Vevzuo for cancer-related bone issues and rare tumours
Vevzuo is authorised for the prevention of bone complications in adults with advanced cancers involving the bone. It is also approved for treating giant cell tumour (GCT) of the bone in adults and skeletally mature adolescents, particularly when surgery is not an option or could lead to severe side effects.
Evfraxy to treat osteoporosis and bone loss
Evfraxy, meanwhile, has been cleared for the treatment of osteoporosis in both postmenopausal women and men at high risk of fractures. It can also be used to manage bone loss caused by hormone ablation therapy in prostate cancer patients, as well as bone damage linked to long-term glucocorticoid use.
Clinical trials confirm safety and effectiveness of two biosimilars
Clinical studies have shown that both biosimilars offer comparable safety, quality, and effectiveness to the original reference drug. This regulatory nod follows a positive opinion from the European Medicines Agency’s CHMP, issued on April 25, 2025.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, reiterated the company’s commitment to expanding access to essential medicines. “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,” Tambe said.
How Denosumab works
Denosumab is a monoclonal antibody that targets a protein called RANKL, which activates osteoclasts—the cells responsible for breaking down bone. By blocking RANKL, Denosumab helps reduce bone loss, increase bone mass, and improve strength.
Widespread need for bone treatments in Europe
According to the Biocon’s report on BSE, Osteoporosis remains a growing concern in Europe, affecting around 32 million people over the age of 50, with 25.5 million being women. It often goes unnoticed until a fall or fracture occurs. In the UK, one in five men over 50 is expected to suffer a bone fracture due to the condition.
Additionally, many cancers can spread to the bone, leading to pain and fractures. In 2022 alone, the EU reported 2.74 million new cancer cases. Giant cell tumours, though rare, can be aggressive and account for 3–5 per cent of primary bone tumours in Europe and the US.
Biocon share price on the rise
The share price of Biocon, the parent company of Biocon Biologics, has seen a strong upward trend in recent months, rising by approximately 9.68 per cent over the past month.
Biocon Biologics has launched nine biosimilars and has a pipeline of 20 more covering key therapeutic areas such as diabetes, cancer, ophthalmology, and bone health.
The company continues to expand its presence in advanced markets like the US, Europe, Australia, Canada, and Japan. It also maintains a strong focus on sustainability and healthcare access, in line with its ESG goals and the UN Sustainable Development Goals.