CHMP recommends approval of teriparatide biosimilar Sondelbay for osteoporosis.- Accord Healthcare

Sondelbay will be available as a 20 µg/80 µl solution for injection. The active substance of Sondelbay is teriparatide, the active aminoterminal fragment of human parathyroid hormone (ATC code: H05AA02). It acts via the receptor for parathyroid hormone and has an anabolic effect on bone. Sondelbay is a biosimilar medicinal product. It is highly similar to the reference product Forsteo (teriparatide), which was authorised in the EU on 10 June 2003. Data show that Sondelbay has comparable quality, safety and efficacy to Forsteo (teriparatide).

The full indication is: Sondelbay is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.