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.
We are excited about the introduction of Terrosa, our first own-developed biosimilar product in Europe, as it reflects our commitment to scientific programmes linked to complex medications such as biologicals. 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, said Gabor Orban, Chief Executive Officer of Richter.