BUDAPEST (Reuters) - Richter received a positive opinion from European regulators recommending that its generic osteoporosis drug Terrosa be granted marketing authorization, the Hungarian drug maker said in a statement on Monday.
Richter said the drug was its first biosimilar product, based on Eli Lily’s Forsteo.
Terrosa will be sold upon regulatory approval after the recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
“The positive CHMP opinion for our first biosimilar teriparatide marks an important milestone for our biosimilars business,” Richter CEO Erik Bogsch said in the statement.
Reporting by Marton Dunai; editing by Jason Neely