Bone Health: Biocon Biologics Receives Positive CHMP Opinions for Biosimilar Denosumab in Europe

BENGALURU, India, April 28, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523) (NSE: BIOCON), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the authorization of its denosumab biosimilars candidates for distinct therapeutic indications for bone health: Vevzuo® and Denosumab BBL  (brand name is currently under approval). 

The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics Ltd.

These recommendations follow a review of comprehensive data packages, including clinical studies results[1], which demonstrated comparability with the reference product in terms of pharmacokinetic, safety, efficacy and immunogenicity profiles. 

Denosumab biosimilar Vevzuo® is intended for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.

Denosumab BBL is intended for the treatment of osteoporosis in women who have been through menopause, treatment of bone loss linked to hormone ablation in men at increased risk of fractures or treatment of bone loss associated with long-term treatment with systemic glucocorticoid.

The European Commission will review the CHMP opinions and, following its decision, detailed information on the authorized indications and usage will be included into the Summary of Product Characteristics (SmPCs) available in all official European Union languages, and the European Public Assessment Reports (EPARs).

Until marketing authorisations are granted by the European Commission, these products are not authorized for use in the European Union. 

About Biocon Biologics Limited: 

Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes.

Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs).

Website www.bioconbiologics.com; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates.

Biocon Limited, publicly listed in 2004, (BSE code: 532523) (NSE Id: BIOCON) (ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. 

Website: www.biocon.com; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates.

All trademarks, registered or unregistered, are the property of their respective owners. 

[1] Anna Strzelecka, Grzegorz Kania, Pawan Kumar Singh, Kuldeep Kumar, Binay Kumar Thakur, Ashwani Marwah, Sudipta Basu, Nitin Madhukar Chaudhari, Sarika S Deodhar, Elena Wolff-Holz, Sandeep Nilkanth Athalye, Subramanian Loganathan.
A Randomized, Double-blind, Multicenter, Parallel-arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity between Bmab-1000 and Prolia in Postmenopausal Women with Osteoporosis. Poster presented at ACR Congress 2024

R. Eastell, E. Orwoll, F. Cosman, A. Strzelecka, G. Kania, R. Plebanski, A. Mansukhbhai Ranpura, K. Kumar, B. Kumar Thakur, A. Marwah, S. Basu, N. Madhukar Chaudhari, S. S Deodhar, E. Wolff-Holz, S. Loganathan. Equivalence Trial of Proposed Denosumab Biosimilar Bmab-1000 And Reference Denosumab In Postmenopausal Osteoporosis: The Devote Study. Poster presented at WCO-IEF-ESCEO 2025

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