European Green Light for Biocon's Bone-Saving Cancer Drugs and Osteoporosis Treatment

Biocon Biologics, a leading name in global biosimilars and a subsidiary of Biocon, has received crucial marketing authorization from the European Commission for two groundbreaking biosimilar drugs: Vevzuo and Evfraxy.

Dual Approval for Critical Bone Health

The EU's endorsement of Vevzuo and Evfraxy, both biosimilar versions of Denosumab, expands vital treatment options. Vevzuo is poised to become a key player in preventing debilitating bone complications in adults with advanced cancers that have spread to the bone. It also offers a much-needed treatment for giant cell tumours (GCT) of the bone in adults and adolescents, especially when surgery isn't a viable option or carries severe risks.

Targeting Osteoporosis and Bone Loss

Meanwhile, Evfraxy will tackle the widespread concern of osteoporosis. It is now approved for treating postmenopausal women and men at high risk of fractures, offering a lifeline to those whose bones have become fragile over time. Additionally, Evfraxy will assist in managing bone loss induced by hormone ablation therapy in prostate cancer patients and bone damage stemming from long-term glucocorticoid use.

Rigorous Trials Confirm Safety and Efficacy

The journey to approval for both biosimilars has been rigorously validated through extensive clinical trials. These studies unequivocally confirmed that Vevzuo and Evfraxy demonstrate comparable safety, quality, and effectiveness to their original reference drug, assuring patients and healthcare providers of their reliability. This positive regulatory outcome follows a favourable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025.

Biocon Biologics' Commitment to Access

Shreehas Tambe, CEO and Managing Director of Biocon Biologics, emphasized the company’s steadfast commitment to broadening access to essential medicines.

Understanding Denosumab: How It Works

At the heart of these new treatments is Denosumab, a monoclonal antibody designed to target a protein called RANKL. This protein is a critical activator of osteoclasts—the very cells responsible for breaking down bone. By effectively blocking RANKL, Denosumab plays a pivotal role in reducing bone loss, increasing bone mass, and ultimately strengthening bones.

Addressing a Widespread Need in Europe

The need for such treatments in Europe is profound. Osteoporosis remains a silent epidemic, affecting an estimated 32 million people over 50 in Europe, with women accounting for 25.5 million of those cases. Often undetected until a fracture occurs, this condition poses a significant public health challenge. In the UK alone, one in five men over 50 is expected to suffer an osteoporosis-related bone fracture. Furthermore, the spread of cancer to bones is a common and painful complication, with 2.74 million new cancer cases reported in the EU in 2022. While rare, giant cell tumours can be aggressive and represent 3-5% of primary bone tumours in the United States and Europe.

Biocon's Growing Market Presence and Future Outlook

The market has responded positively to Biocon's continued success, with the parent company's share price experiencing a notable upward trend, rising approximately 9.68% over the past month.

Biocon Biologics boasts an impressive portfolio, having already launched nine biosimilars, with an additional 20 in its pipeline spanning critical therapeutic areas such as diabetes, cancer, ophthalmology, and bone health. The company continues to solidify its presence in advanced markets globally, including the US, Europe, Australia, Canada, and Japan, all while maintaining a strong commitment to sustainability and accessible healthcare, aligning with its ESG goals and the UN Sustainable Development Goals.

(Rh/Dr. Divina Johncy Rosario/MSM/SE)