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Aurobindo’s CuraTeQ Withdraws European Biosimilars – But They Will Be Back

EMA Refiling Expected After Filgrastim And Pegfilgrastim Applications Withdrawn

 
• By Dave Wallace

Aurobindo’s CuraTeQ has withdrawn EMA filings for its filgrastim and pegfilgrastim biosimilars over inspection timing issues – but expects to refile the products as it works towards obtaining the necessary EU GMP certification.

Withdrawal word highlighted in dictionary
CuraTeQ has withdrawn two biosimilar filings • Source: Shutterstock

Aurobindo subsidiary CuraTeQ Biologics has withdrawn two European Medicines Agency filings for biosimilars, after timing issues connected with facility inspections prevented the firm from obtaining the requisite EU good manufacturing practice certification within the necessary window.

However, the company intends to resubmit marketing authorization applications for the filgrastim and pegfilgrastim biosimilars as it

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