Gedeon Richter Predicts Two-Year Wait To Refile Pegfilgrastim, But Teriparatide Is In The Wings
A timeline to refile, for a second time, its proposed biosimilar to Neulasta with the EMA and plans to launch its biosimilar to Eli Lilly’s Forsteo across the EU featured on Gedeon Richter’s full-year earnings call for 2018.
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Stada and Gedeon Richter have launched their respective Movymia and Terrosa teriparatide biosimilars in Europe, with Stada eyeing 24 individual countries.
Launching the oncology drug bortezomib in 14 European countries helped Stada to record an 11% increase in both Generics and group sales in the first half of 2019. But the German group, which is about to start rolling out biosimilar teriparatide, has suffered a legal setback on pemetrexed in its home market.
The EMA has formally accepted for filing Alvogen and Pfenex’ centralized marketing authorization application for a biosimilar rival to Lilly’s Forsteo teriparatide blockbuster.