Zefylti (filgrastim biosimilar) / Aurobindo - LARVOL DELTA

Aurobindo Pharma arm’s biosimilar gets marketing nod from U.K.’s MHRA (The Hindu) - "Aurobindo Pharma subsidiary CuraTeQ Biologics s.r.o. has received marketing authorisation for Zefylti, its filgrastim biosimilar version, from Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K."

MHRA approval • Neutropenia

Aurobindo Pharma’s arm gets marketing authorization for Zefylti (MoneyWorks4Me) - "Aurobindo Pharma’s wholly owned step-down subsidiary -- CuraTeQ Biologics s.r.o. has received marketing authorization from The European Commission (EC) in the European Union for Zefylti, a filgrastim biosimilar. "

EMA approval • Neutropenia

CuraTeQ Biologics receives positive opinion for biosimilar Zefylti (Aurobindo Press Release) - "CuraTeQ Biologics Private Limited...is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion for Zefylti (BP13, a filgrastim biosimilar) recommending the granting of a marketing authorisation. Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs)."

CHMP • Neutropenia