Positive CHMP opinion for for Osvyrti, a denosumab biosimilar for treatment of osteoporosis and bone loss- Accord Healthcare

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Osvyrti, intended for for the treatment of osteoporosis in women who have been through menopause, in men with prostate cancer who are at increased risk of fractures and whose bone loss is linked to hormone ablation and people whose bone loss is linked to long-term treatment with systemic glucocorticoid. The applicant for this medicinal product is Accord Healthcare S.L.U. Osvyrti will be available as a 60 mg solution for injection in pre-filled syringes. The active substance of Osvyrti is denosumab, a drug for the treatment of bone diseases (ATC code: M05BX04).

Osvyrti 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 Osvyrti has comparable quality, safety and efficacy to Prolia (denosumab).

The full indication is: treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.

Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.

Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.