Hungarian Richter withdraws biosimilar drug marketing authorisation application from EMA
December 19, 2016Gedeon Richter Plc., a Hungarian drugmaker has withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for its biosimilar pegfilgrastim.
The company said on Monday that the MAA filing was based on comparative quality, non-clinical and clinical data from the its completed biosimilar development programme.
Richter said that, during the November 2016 Committee for Medicinal Products for Human Use (CHMP) meeting, the CHMP indicated that the data provided did not allow the Committee to conclude a positive benefit risk assessment.
“The Company’s management is committed to continue the clinical development and
regulatory process of its biosimilar pegfilgrastim in order to eliminate the remaining
uncertainties identified by CHMP during the review process,” Richter said in a Budabest Stock Exchange filing.
