Biocon Biologics gains favorable CHMP opinions for denosumab biosimilars in Europe
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Denosumab BBL, 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 applicant is Biosimilar Collaborations Ireland Limited, a Biocon Biologics subsidiary company. Denosumab BBL is a biosimilar medicinal product. It is highly similar to the reference product Prolia (denosumab), which was authorised in the EU on 26 May 2010. Data show that Denosumab BBL has comparable quality, safety and efficacy to Prolia.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
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