Novartis Withdraws Drug Application for Biosimilar Zioxtenzo

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Application pulled for biosimilar that treats neutropenia.

Novartis AG has withdrawn its new drug application from the European Medicines Agency (EMA) for biosimilar Zioxtenzo.

Zioxtenzo is a biosimilar of Amgen’s pegfilgrastim (Neulasta), which treats neutropenia in patients with cancer. Neutropenia can occur when cancer causes an abnormally low white blood cell count of neutrophils, which can damage the bone marrow, according to Investopedia.

Although the application was submitted to the EMA a year ago, there have been numerous unfavorable developments. Novartis chose to withdraw its application, stating it would be unable to provide the required data to the agency by the deadline.

The EMA cited 2 concerns regarding Novartis’ drug application. The first issue was that the study results did not show the same concentration levels of pegfilgrastim in the blood after taking Zioxtenzo and Neulasta. Secondly, the EMA was concerned with the lack of a Good Manufacturing Practice certificate for the drug’s manufacturing site, Investopedia reported.

These 2 concerns had not been addressed by the time the drug application was withdrawn.

Zioxtenzo was rejected by the FDA in 2016, and after Novartis received a complete response letter, it said it would work to address the issues raised by the FDA.

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