BUDAPEST (Reuters) - Hungarian pharmaceuticals firm Richter has withdrawn its marketing application for one of its biosimilar drugs from the European Medicines Agency in anticipation of a possible negative assessment, the company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 Committee for Medicinal Products for Human Use (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.
A biosimilar medicine is a biological medicine that is developed to be highly similar to an already authorised biological medicine, Richter said in its statement.
Richter said in November its third-quarter net profit doubled from the same period last year thanks to higher revenue and it lifted its 2016 profit forecast.
Reporting by Krisztina Than; editing by David Clarke