Richter’s pegfilgrastim biosimilar application accepted by EMA

Gedeon Richter Plc., Hungarian pharmaceutical producer, has announced on Tuesday that the European Medicines Agency (EMA) has accepted Richter’s regulatory submission for its proposed biosimilar to Amgen’s Neulasta (pegfilgrastim).

Richter signed a license and distribution agreement for the product earlier this year with Stada.

The biosimilar pegfilgrastim has been developed by Richter. According to the license and distribution agreement signed by Richter and Stada earlier this year, biosimilar pegfilgrastim is expected to be launched under both Richter and Stada labels in geographical Europe (excluding Russia) following the patent expiry of the original product.

Richter is seeking approval for the same indications as the reference product. Pegfilgrastim is a prescription medicine administered to reduce the chance of infections related to a low white blood cell count in patients with cancer who receive chemotherapy.