Sandoz withdraws application at EMA for approval of Zioxtenzo (pegfilgrastim biosimilar).
The Sandoz application for a marketing authorisation at EMA for Zioxtenzo (pegfilgrastim biosimilar) has been withdrawn. Zioxtenzo was developed as a biosimilar medicine to treat neutropenia in cancer patients as a alternative to Neulasta (pegfilgrastim) ,a long-acting granulocyte colony stimulating factor.
A concern was that study results were not able to show that the concentrations of pegfilgrastim in the 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 would therefore be needed before the medicine can be approved.
Sandoz has received a Complete Response Letter from the FDA in relation to its application for Zioxtenzo in the USA.
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