STADA Arzneimittel AG was informed by Gedeon Richter that the European Medicines Agency (EMA) has accepted the regulatory resubmission of its proposed biosimilar to Amgen’s Neulasta (pegfilgrastim).
The resubmission follows the successful completion of an additional clinical study, which provided data demonstrating biosimilarity of both the pharmacokinetics and pharmacodynamics of the proposed biosimilar and Neulasta. The biosimilar pegfilgrastim is currently under review by the EMA for the same indications as the reference product.
In December 2016 Richter withdrew its Marketing Authorization Application (MAA) from the EMA for biosimilar pegfilgrastim, following a CHMP (Committee for Medicinal Products for Human Use) meeting, according to which it has been indicated that the data provided did not allow the Committee to conclude a positive benefit risk assessment.
According to the license and distribution agreement signed by STADA and Richter in 2015, upon approval, biosimilar pegfilgrastim is expected to be launched under both STADA and Richter labels in the European Economic Area.