Hungary-based Gedeon Richter announced today that it has launched a biosimilar teriparatide, Terrosa, in Europe. The drug, referencing Eli Lilly’s Forsteo (sold as Forteo in the United States), is used to treat osteoporosis. The product will also be sold under the brand name Movimya by the company’s partner, Stada.
The biosimilar, a recombinant parathyroid hormone that stimulates bone formation like its reference, was authorized by the European Commission in 2017. Since that time, Gedeon Richter has been awaiting the European patent expiry for the reference drug this month.
“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,” Gábor Orbán, chief executive officer of Richter-Helm BioTec, said in a statement. “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,” he added.
The biosimilar will be available in a reusable pen, called ServoPen Fix, which will last for a full 2-year treatment cycle. The pen is intended to be both comfortable for the patient and environmentally sustainable.
The clinical program for the biosimilar consisted of a single comparative pharmacokinetic (PK) study in 54 healthy volunteers; according to the European Medicines Agency, this single study was considered acceptable in principles because teriparatide is a small and relatively simple biologic.