European regulators have accepted a resubmission of Gedeon Richter’s biosimilar to Amgen’s Neulasta.
In December 2016 Richter pulled back its application for the drug from the European Medicines Agency, after the Committee for Medicinal Products for Human Use indicated that the data provided would not allow it to determine a positive benefit risk profile.
The company subsequently refiled a submission with new data from an additional clinical study, which, it says, demonstrated "biosimilarity of both the pharmacokinetics and pharmacodynamics of the proposed biosimilar and Neulasta.”
The biosimilar is under review by the EMA for the same indications as the reference product, that is for reducing the duration of neutropaenia and the occurrence of febrile neutropaenia.
If approved, biosimilar pegfilgrastim is expected to be launched under both STADA Arzneimittel and Richter labels in the European Economic Area.
EU regulators are also currently also reviewing Novartis group Sandoz’ Neulasta biosimilar.