Aurobindo Pharma arm’s biosimilar will get EMA panel nod 

Aurobindo Pharma subsidiary CuraTeQ Biologics has acquired optimistic opinion for Zefylti, its biosimilar of filgrastim, from the Committee for Medicinal Merchandise for Human Use (CHMP) of the European Medicines Company (EMA).

The CHMP has adopted a optimistic opinion for Zefylti (BP13) recommending the granting of a advertising and marketing authorisation. Zefylti will probably be out there as 30 MU/0.5 mL and 48 MU/0.5 mL and is meant for the remedy of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs), Aurobindo stated on Friday.

“After receiving the GMP certificates of compliance from the EMA in November, Zefylti is our first biosimilar to obtain a optimistic opinion from the CHMP. Our biosimilar variations of pegylated filgrastim (BP14) and trastuzumab (BP02) are below evaluation with the EMA and a biosimilar to bevacizumab (BP01) is below evaluation with the MHRA. We’re assured and on observe to convey these remedy choices to sufferers subsequent yr,” the corporate stated in a launch.