Alvogen Targets Esmya With First European Rival
Alvogen has gained multiple European approvals for a rival to Gedeon Richter’s Esmya through the decentralized procedure.
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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.
Sales of the uterine fibroid therapy, Esmya, sharply declined during the first half of 2018 at Hungary's specialty pharmaceuticals company, but an EU review of a potential association between the drug and liver injury has now been completed.
The European Medicines Agency’s pharmacovigilance committee has recommended more restrictions on the use of Richter’s Esmya because of concerns over the risk of serious liver damage.