Aurobindo Pharma's Subsidiary Recalls Marketing of 2 Biosimilars after EU-GMP Rejection

27 Jun 2023 , 03:11 PM

CuraTeQ Biologics has received approval from the European Union drug watchdog to withdraw its applications for marketing authorization for two of its products, according to a statement released by the company to the stock exchanges.

The decision to withdraw the applications came after CuraTeQ Biologics failed to obtain the European Union Good Manufacturing Practice (EU-GMP) certification for its biosimilar manufacturing facility within the Day 180 clock-stop period, with no further clock-stop extensions granted.

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma Limited, made the decision to pull out the dossiers for its products, namely ZEFYLTI (a filgrastim biosimilar) and DYRUPEG (a pegfilgrastim biosimilar), after consulting with the Committee for Medicinal Products for Human Use under the European Medicines Agency (EMA) and receiving guidance from them.

Aurobindo Pharma Limited, the parent company, has stated that it will collaborate with the regulatory agency to resubmit the applications as soon as possible. The company emphasized that the withdrawal will not have any negative impact on future filings or ongoing clinical studies, as it is a procedural matter.

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