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Biocon Biologics Receives Positive CHMP Opinions for Denosumab Biosimilars

In a significant advancement for bone health treatments, Biocon Biologics Ltd (BBL), a subsidiary of the renowned Biocon Ltd, has announced the approval of its denosumab biosimilars by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. This decision paves the way for the commercialization of its biosimilar candidates, Vevzuo® and the Denosumab BBL, which are designed for different therapeutic indications related to bone health.

Key Highlights of the CHMP Recommendations

The recommendations from CHMP were based on thorough assessments of comprehensive data submitted by Biosimilar Collaborations Ireland Limited, another subsidiary wholly owned by Biocon Biologics. The application packages included detailed results from clinical studies that highlighted the comparability of their biosimilars with the reference product, specifically focusing on pharmacokinetic profiles, safety, efficacy, and immunogenicity.

The specific indications for each biosimilar are as follows:

• - Vevzuo®: This biosimilar is aimed at preventing bone complications in adults suffering from advanced cancer involving the bones and treating adults and skeletally mature adolescents with giant cell tumor of bone.
• - Denosumab BBL: This product targets the treatment of osteoporosis in postmenopausal women and addresses bone loss linked to hormone ablation in men, as well as bone loss occurring from long-term treatment with systemic glucocorticoids.

Future Steps

The next steps involve a review of these positive opinions by the European Commission, which will ultimately determine the authorization of the biosimilars. Following its decision, the authorized indications and usage will be detailed in official documents such as the Summary of Product Characteristics (SmPCs) and the European Public Assessment Reports (EPARs), which will be available in all official languages of the European Union. Until that time, the products remain unauthorized for use within the EU.

About Biocon Biologics

Biocon Biologics Ltd. stands out as a fully integrated global biosimilars company committed to improving healthcare. It is focused on providing high-quality biosimilars at affordable prices across over 120 countries. With a comprehensive approach from research to market, Biocon Biologics utilizes innovative technologies and world-class manufacturing processes to enhance treatment outcomes while reducing costs.

The company has successfully commercialized eight biosimilars in various markets, including the US, Europe, Australia, Canada, and Japan. Furthermore, it boasts a robust pipeline of 12 biosimilar assets under development across different therapeutic areas such as diabetology, oncology, immunology, and ophthalmology.

Biocon Biologics continues to strive for excellence in the biosimilars industry, having garnered many 'firsts' to its credit. Its commitment extends beyond healthcare into environmental and social governance (ESG), aligning its goals with the UN Sustainable Development Goals (SDGs) to promote global health and well-being.

For more information, visit Biocon Biologics and follow them on X (formerly Twitter) and LinkedIn for the latest updates.

Biocon Limited, which became publicly listed in 2004, is an innovation-led global biopharmaceutical company dedicated to making complex therapies accessible. It has a plethora of offerings ranging from biosimilars to complex small molecule APIs and continues to explore promising novel assets in immunotherapy.

For further details, visit Biocon and follow their updates on X and LinkedIn.