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CuraTeQ Biologics withdraws EMA MA applications for biosimilars ZEFYLTI® (filgrastim) and DYRUPEG® (pegfilgrastim)

Jun 26, 2023

Aurobindo Pharma subsidiary CuraTeQ Biologics informed stock exchanges that it has withdrawn marketing authorisation applications to the EMA for biosimilars ZEFYLTI®, biosimilar to Amgen’s Neupogen® (filgrastim) and DYRUPEG®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The withdrawal was made after guidance was received from EMA, which advised the Company it will not obtain EU-GMP certification of its biosimilars manufacturing facility within the current Day 180 clock stop period, which would not be extended.  CuraTeQ confirmed it will work with the EMA to re-submit the applications as soon as possible.

On 11 January 2022, Orion Corporation and CuraTeQ Biologics announced an expansion to their biosimilar distribution agreement in Europe.