Biocon Biologics Ltd , a fully integrated global biosimilars company and subsidiary of Biocon Ltd 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.
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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, 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.
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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.
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Source – PR Newswire
