EMA accepts Richter’s Neulasta pegfilgrastim
Hungarian drugmaker Gedeon Richter’s regulatory submission for its proposed biosimilar to Amgenʼs Neulasta (pegfilgrastim) has been accepted by the European Medicines Agency (EMA), Richter announced today.
According to the license and distribution agreement signed by Richter and STADA earlier this year for biosimilar pegfilgrastim, which was developed by Richter, the medicine is to be launched under both Richter and STADA labels in geographical Europe (excluding Russia) following the patent expiry of the original product, the announcement said.
Richter added that it is seeking approval for the same indications as the reference product.
Pegfilgrastim is a prescription medicine administered to reduce the possibility of infection related to a low white blood cell count in patients with cancer who receive chemotherapy, the company notes.
Gedeon Richter, headquartered in Budapest, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe. Richterʼs consolidated sales were approximately €1.1 billion, while its market capitalization amounted to €2.1 bln in 2014, the company said.
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