Denosumab biosimilar (Biocon)

The European Commission (EC) has approved Biocon Biologics’ biosimilars referencing Amgen’s bone disease therapy denosumab. Biocon Biologics’ Vevzuo has been authorised to prevent bone complications in adults with advanced cancer involving the bone, and to treat adults and skeletally mature adolescents with giant cell tumour (GCT) of the bone. Meanwhile, the company’s Evfraxy has been approved to treat osteoporosis in men and postmenopausal women, as well as bone loss linked to hormone ablation in men with prostate cancer at an increased risk of fractures. The drug has also been approved to treat bone loss associated with long-term systemic glucocorticoid therapy in adults. A biosimilar, according to the European Medicines Agency (EMA), is a biological medicine that is highly similar to one already approved in the EU. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product. The EC’s decision on Vevzuo and Evfraxy follows a recent recommendation from the EMA’s human medicines committee and was supported by clinical data showing that both biosimilars have comparable quality, safety and efficacy to the reference product. An estimated 32 million people aged 50 years and over in Europe were living with osteoporosis in 2019. The disease, which disproportionately impacts women, weakens bones and makes them more likely to break. Additionally, almost all types of cancer can spread to the bone and cause pain and fractures, while GCTs, benign tumours that typically occur in young adults, can grow quickly and destroy surrounding bone and soft tissue. Denosumab is a human monoclonal antibody that is designed to increase bone mass and strength by blocking the action of the RANKL protein, which plays a critical role in the formation, function and survival of osteoclasts. Biocon Biologics’ chief executive officer and managing director, Shreehas Tambe, said: “These denosumab biosimilars mark another significant milestone in our rapid expansion, and support for healthcare systems in the region.” The authorisation comes less than five months after the EC approved Biocon Biologics’ Yesintek, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat multiple inflammatory diseases.