#None #Denosumab #Biocon Biologics #Vevzuo

Advancing Bone Health

In a significant advancement for bone health, the European Commission has provided marketing authorization for Biocon Biologics' new biosimilars of Denosumab, known as Vevzuo® and Evfraxy®. This approval marks an important step forward in the treatment options available for adults suffering from advanced cancer-related bone complications and osteoporosis.

Background on Biocon Biologics

Biocon Biologics Ltd, a subsidiary of Biocon Ltd, is a fully integrated global biosimilars company focused on increasing patient access to essential medications. The recently approved biosimilars, Vevzuo and Evfraxy, were developed following extensive research and clinical trials demonstrating their safety and efficacy comparable to the reference product, Denosumab.

The Approved Biosimilars

1. Vevzuo®: This biosimilar is specifically authorized for preventing bone complications in adults with advanced malignancies involving bone. Additionally, it is designed for treating adults and skeletally mature adolescents diagnosed with giant cell tumors of the bone. Giant cell tumors, while benign, can be locally aggressive and detrimental, emphasizing the need for effective treatment options.

2. Evfraxy®: Approved for treating osteoporosis in both men and postmenopausal women, Evfraxy also addresses bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adults. Osteoporosis is a significant health concern, contributing to fractures and overall bone fragility, particularly in older populations.

Clinical Data and Efficacy

Clinical data affirm that both Denosumab biosimilars maintain an equivalent quality, safety profile, and efficacy when compared to the original product. The positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use on April 25, 2025, paved the way for these approvals, underscoring Biocon's commitment to enhancing patient care in critical therapeutic areas.

Shreehas Tambe, CEO and Managing Director, emphasized the importance of this development: “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.”

Addressing a Growing Problem

Osteoporosis, which affects an estimated 32 million individuals aged 50 and older in Europe alone, represents a growing challenge in geriatric health management. The disease can lead to painful fractures and has catastrophic implications for mobility and quality of life. With nearly one in five men over 50 likely to suffer a fracture due to osteoporosis, the introduction of effective treatment options is more critical than ever.

Cancer also increasingly poses risks to bone health; studies reveal that various cancer types can metastasize to bones, exacerbating pain and complications. Reports from 2022 indicated an alarming 2.74 million new cancer cases in the EU, highlighting the urgent need for advanced medical solutions targeting bone health.

Biocon’s Dedication to Innovation

As a leader in the biosimilars industry, Biocon Biologics is committed to developing a wide range of innovative treatment options. With a pipeline of 20 biosimilar assets aimed at diverse conditions including diabetes, oncology, and now bone health, the company seeks to enhance quality of care while fostering affordability. Through its competitive edge in scientific research, manufacturing, and distribution, Biocon aims to serve over 5.8 million patients across more than 120 countries.

By combining cutting-edge science with a strong commitment to patient welfare, Biocon Biologics is positioned as a transformative force in the healthcare sector, fulfilling essential needs and promoting overall health initiatives. The ongoing development of biosimilars like Vevzuo and Evfraxy exemplifies the company’s mission to enable better access to high-quality therapeutic solutions for chronic and complex conditions.

For more information on Biocon Biologics and its range of biosimilars, you can visit their official website www.bioconbiologics.com or follow them on social media platforms for updates.