Gedeon Richter Plc. (“Richter”) today announced that it has launched its biosimilar teriparatide, Terrosa® in Europe. The product is approved in adults for the same indications as Eli Lilly’s Forsteo®, i.e. used for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.
Biosimilar teriparatide has been developed by Richter-Helm BioTec GmbH & Co. KG. The product has been launched under the label Terrosa® by Richter via its affiliates in Europe immediately following the patent expiry of the reference product in August 2019.
The European Commission (EC) approved Terrosa® in January 2017, following the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the data derived from the comprehensive physico-chemical and biological characterisation, in vivo non-clinical studies and the clinical trial, constituting the development programme of Terrosa® had demonstrated biosimilarity with Forsteo ®. The EC approval of Terrosa® applies to all 28 European Union (EU) member states and European Economic Area (EEA) member states.
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.
Teriparatide is biosimilar to the biologically active fragment of the human parathyroid hormone, it replaces the natural hormone and stimulates bone formation. Teriparatide is used for the treatment of osteoporosis as it reduces the risk of bone fracture in various patient groups. Osteoporosis is more common in women after the menopause, but it can occur in both men and women as a side effect of glucocorticoid treatment.