EMA evaluating Richter's application for biosimilar teriparatide

9 January 2016

Hungary's largest drugmaker Gedeon Richter (RICHT: HB) says that the European Medicines Agency has accepted Richter's regulatory submission for the proposed biosimilar to teriparatide.

Teriparatide is the active ingredient US pharma major Eli Lilly’s osteoporosis treatment Forteo, which generated sales of $348.9 million in the third quarter of 2015.

The biosimilar teriparatide has been developed by its Richter-Helm BioTec GmbH subsidiary. According to the relevant license agreements, biosimilar teriparatide is expected to be launched under both Richter and STADA (Germany’s Stada Arzneimittel [SAZ: Xetra] labels in geographical Europe following the patent expiry of the original product.

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