The product is approved in adults for the same indications as American pharmaceutical company Eli Lilly’s Forsteo, used for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, as well as treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture, said the press release.

In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated, Richter says. The biosimilar teriparatide has been developed by Richter-Helm BioTec GmbH & Co. KG.

The product is being 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). The EC approval of Terrosa applies to all 28 EU member states and European Economic Area (EEA) member states.

“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 such as biologicals,” said Richter CEO Gábor Orbán. “Biosimilars will increase choice and access for patients in 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.”