Biocon Biologics Secures Positive CHMP Opinions for Denosumab Biosimilar in Europe

Biocon Biologics Gets Positive CHMP Opinions for Denosumab Biosimilar in Europe

Biocon Biologics Ltd (BBL), a leading global player in the biosimilars market and a subsidiary of Biocon Ltd, recently announced that it has received favorable recommendations from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for its Denosumab biosimilar candidates, Vevzuo® and Denosumab BBL. These biosimilars are developed for various therapeutic indications related to bone health.

The positive opinions are based on comprehensive data submissions made by Biosimilar Collaborations Ireland Limited, a wholly-owned subsidiary of Biocon Biologics. The CHMP's recommendations are supported by an extensive evaluation of datasets that demonstrate the biosimilars' comparability to the reference product in terms of pharmacokinetics, safety, efficacy, and immunogenicity.

Focus on Bone Health

The Denosumab biosimilar, Vevzuo®, is designed to prevent bone complications in adults with advanced bone cancer and is also indicated for treating adults and adolescents with giant cell tumors of the bone. Meanwhile, Denosumab BBL is intended for the treatment of osteoporosis in postmenopausal women, addressing bone loss in men after hormonal ablation and for those experiencing bone loss due to long-term systemic glucocorticoid treatment.

The next steps involve the European Commission (EC) reviewing the CHMP opinions. Upon receiving approval, detailed information regarding the indications and usage will be integrated into the product's marketing authorizations (SmPCs) and the European public assessment reports (EPARs), which will be accessible in all European Union (EU) official languages. Until the EC grants marketing authorization, these products are not permitted for use within the EU.

Biocon Biologics: A Leader in Transformation

Biocon Biologics is a unique fully integrated global biosimilars company committed to transforming healthcare and enhancing lives. With its extensive “Lab-to-Market” capabilities, the company strives to provide affordable access to high-quality biosimilars for millions of patients across over 120 countries. Through the application of cutting-edge science and innovative technology, Biocon Biologics aims to reduce the costs of biological therapeutics while simultaneously improving healthcare outcomes.

To date, Biocon Biologics has launched nine biosimilars in key emerging and developed markets, including the United States, Europe, Australia, Canada, and Japan. The company's robust pipeline includes 20 biosimilar products currently under development, targeting a variety of therapeutic areas including diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases.

In its commitment to environmental, social, and governance (ESG) principles, Biocon Biologics focuses on enhancing the health of patients and the planet, contributing to the United Nations Sustainable Development Goals.

For ongoing updates about the company, visit Biocon Biologics or follow them on social media platforms like X (formerly Twitter) and LinkedIn.