The European Union drug watchdog has acknowledged a request of CuraTeQ Biologics to remove the applications for marketing authorisation of its two products, the company updated the stock exchanges.

The request came after the firm failed to get the European Union Good Manufacturing Practice (EU-GMP) certification for the biosimilar manufacturing unit within the Day 180 clock-stop period and no further clock-stop allowances.

CuraTeQ Biologics SRO, a wholly owned step-down secondary of Aurobindo Pharma Limited, required to pull out the two dossiers – ZEFYLTI, a filgrastim biosimilar, and DYRUPEG, a pegfilgrastim biosimilar – after essential consultations and receiving direction from the Committee for Medicinal Products for Human Use under the European Medicines Agency (EMA).

The leading drug pharma said it would work with the agency to re-submit the requests at the earliest and repeated that the withdrawal would not influence any future filings or continuing clinical studies as it is procedural.