Hungarian Pharma Firm Launches New Product

Hungarian pharmaceutical company Gedeon Richter Plc. said that it launched a biosimilar teriparatide drug called Terrosa® in Europe. The product is approved in adults for the same indications as Eli Lilly’s Forsteo® and is used for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. Terrosa is also used for the 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, excluding hip fractures, has been demonstrated as a result of the use of Terrosa.
The drug has been developed by Richter-Helm BioTec GmbH & Co. KG and it has been launched under the label Terrosa® by Richter via its affiliates in Europe following the patent expiry of the reference product in August 2019, according to a press release issued by the company.
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 characterization, in vivo non-clinical studies and the clinical trial had demonstrated biosimilarity with Forsteo®. The EC's approval of Terrosa® applies to all 28 European Union (EU) member states and European Economic Area (EEA) member countries.
“We are excited about the introduction of Terrosa®, our first own-developed biosimilar product in Europe, as it reflects our commitment to scientific programs linked to complex medications. Biosimilars will increase choice and access for patients in the European countries, while providing potential cost savings to healthcare systems. We look forward to bringing more high quality and affordable biosimilar products to the market,” Richter CEO Gábor Orbán commented.