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Sandoz withdraws Zioxtenzo (pegfilgrastim) European application
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Amgen EMA Europe GMP Neulasta Novartis pegfilgrastim Sandoz withdrawal Zioxtenzo
On 18 January 2017, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zioxtenzo, intended for treating neutropenia in patients taking cancer treatments.
Zioxtenzo is a medicine that contains the active substance pegfilgrastim. It was developed as a ‘biosimilar’ medicine. This means that it was intended to be highly similar to the ‘reference medicine’) already authorised in the European Union. The reference medicine for Zioxtenzo is Neulasta.
At the time of withdrawal, Sandoz had already presented results of studies designed to show that Zioxtenzo is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine. In addition, two studies in patients receiving cancer medicines compared the safety and effectiveness of Zioxtenzo and Neulasta.
Based on the review of the data, at the time of the withdrawal, the CHMP had two main concerns and was of the provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta.
One concern was that study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta. The other concern was the lack of a certificate of Good Manufacturing Practice (GMP) for the medicine’s manufacturing site. An inspection of the site will therefore be needed before the medicine can be approved.
At the time of the withdrawal, the company had not demonstrated that Zioxtenzo is highly similar to Neulasta and an inspection to confirm that it was being manufactured according to GMP standards had not yet taken place.
In its letter notifying EMA of the withdrawal of the application, Sandoz stated that it would not be able to provide the additional data required by the CHMP within the timeframe allowed for the procedure. The withdrawal letter is available here.
Source: EMA
