Gedeon Richter Launches Teriparatide Biosimilar in Europe

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 Gedeon Richter, 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.

The single-center, single-dose, 2-stage, 2-period crossover study compared the PK of the biosimilar with that of the EU-licensed reference; the volunteers were randomized to receive either a single dose (20 μg/80 μL via subcutaneous injection) of the biosimilar followed by a single dose of the reference, or vice versa.

The primary PK parameters were area under the plasma concentration versus time curve to the last measurable concentration and maximum plasma concentration. Equivalence was determined if the 94.12% confidence intervals of the ratios of geometric least squares means of the biosimilar to the reference were contained within the prespecified equivalence margin of 80% to 125%. For the 2 end points, respectively, the geometric mean ratios of 91.66% and 92.25% fell within the prespecified margin.

The drug makers also supplied supportive data from this study to inform its documentation of the reference products’ pharmacodynamic properties.

While Gedeon Richter’s product has been authorized and launched as a biosimilar in the European Union, US patients are likely to see only follow-on versions of teriparatide become available to them; teriparatide is not on the FDA’s preliminary list of products that will transition from regulation as drugs to regulation as biologics in 2020.

To date, at least 1 US follow-on has been proposed; drug maker Pfenex has submitted to the FDA a New Drug Application for its follow-on teriparatide, PF708. When the drug maker submitted its application in December 2018, it said that it expected a commercial launch of the product as early as the fourth quarter of 2019.