RICHTER WITHDRAWS ITS EUROPEAN APPLICATION FOR PEGFILGRASTIM BIOSIMILAR

Biosimilar News  •  EMA News

Earlier this week, Hungarian pharmaceutical maker Gedeon Richter Plc. announced that is has withdrawn its Marketing Authorization Application for its pegfilgrastim biosimilar from the European Medicines Agency. According to the announcement, the Committee for Medicinal Products for Human Use (CHMP) expressed that “the data provided did not allow the Committee to conclude a positive benefit risk assessment.”

The announcement also suggests that Richter plans to address the concerns raised by the committee. “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.”

Download PDF

Comments are closed.