CHMP adopts a positive opinion for Rolcya (denosumab biosimilar)

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Rolcya, intended for the treatment of osteoporosis in women who have been through menopause, bone loss linked to hormone ablation in men with prostate cancer who are at increased risk of fractures and bone loss in adults linked to long-term treatment with systemic glucocorticoid. The applicant is Sandoz GmbH. Rolcya is a biosimilar  It is highly similar to the reference product Prolia (denosumab), which was authorised in the EU on 26 May 2010.  Data show that Rolcya has comparable quality, safety and efficacy to Prolia (denosumab). 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.