The EMA announced on January 27 that Novartis and Sandoz have withdrawn their marketing application for their pegfilgrastim biosimilar (Zioxtenzo). The application was withdrawn after the Committee for Medicinal Products for Human Use (CHMP) had two main concerns and was of the provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta.
First, study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta. Second, there was a lack of a certificate of Good Manufacturing Practice (GMP) for the medicine’s manufacturing site. An inspection of the site would therefore have be needed before the medicine could be approved.
As we have previously reported, FDA approval of Sandoz’s proposed pegfilgrastim biosimilar will likely be delayed until at least 2018 due to the need to complete a further study and submit data to FDA. There has been no update on the FDA application yet.
For more biosimilar news, stay tuned to Big Molecule Watch.