EMA to evaluate Richter’s new drug teriparatide


The European Medicines Agency (EMA) has accepted Hungarian drugmaker Gedeon Richter’s regulatory submission for the proposed biosimilar to Eli Lilly’s Forteo (teriparatide), according to a press release issued by the company today.

Biosimilar teriparatide was developed by Richter-Helm BioTec GmbH & Co. KG, based in Hamburg, and according to license agreements, the new drug will be launched under both Richter and STADA labels in geographical Europe once the patent of the original product has expired, the press release noted.

“Teriparatide is prescription only medicine used for the treatment of osteoporosis, leading to frequent bone fractures,” according to the press release. Richter added that Teriparatide is identical to the biologically active fragment of the human parathyroid hormone and replaces the natural hormone to stimulate bone formation.

Gedeon Richter Plc., a major player in the Central Eastern Europe pharmaceutical industry, had consolidated sales of approximately €1.1 billion ($1.5 bln), while its market capitalization amounted to €2.1 bln ($2.5 bln) in 2014, the company said.


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