Posted by Michael Wonder on 22 Dec 2016
Richter withdraws marketing application for biosimilar drug
19 December 2016 - Hungarian pharmaceuticals firm Richter has withdrawn its marketing application for one of its biosimilar drugs from the EMA in anticipation of a possible negative assessment, the company said on Monday.
In Budapest Stock Exchange filing, Richter said that at a November meeting, the CHMP indicated "that the data provided did not allow the Committee to conclude a positive benefit risk assessment" for Richter's biosimilar pegfilgrastim product.
"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.
