M/s. CuraTeQ Biologics s.r.o.'s, a wholly owned step-down subsidiary of Aurobindo Pharma Ltd, has requested to withdraw the applications for Marketing Authorization of ZEFYLTI (a filgrastim biosimilar) and DYRUPEG (a pegfilgrastim biosimilar) has been accepted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA as we will not be able to obtain EU-GMP certification for its biosimilars manufacturing facility within the current Day 180 clock stop period and no further clock-stop extensions would be possible at this stage of the review procedure by CHMP. The company will be working with the Agency to re-submit these applications at the earliest.

The company reiterated that this withdrawal is procedural in nature and does not impact any future filings and / or ongoing clinical studies. It is company's intent to seek re-submission of these filings for Marketing Authorisation with EMA at the earliest.