The European Medicines Agency (EMA) has accepted Hungary-based pharmaceutical company Richter’s regulatory submission for its proposed biosimilar pegfilgrastim, a prescription medicine used in cancer patients to help with some of the side effects of their treatment. Richter’s self-developed medicine is administered to reduce the chance of infections related to a low white blood cell count in patients with cancer who receive chemotherapy, the company said on its website.
According to the license and distribution agreement signed by Richter and German partner company 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.
Having the largest R&D unit in Central Eastern Europe, Budapest-based Gedeon Richter Plc. is a major pharmaceutical company in Central Eastern Europe. Richter’s consolidated sales were approximately EUR 1.1 billion, while its market capitalization amounted to EUR 2.1 billion last year. The product portfolio of Richter covers almost all important therapeutic areas, including gynaecology, central nervous system, and cardiovascular areas.