Spectrum Pharmaceutecals Inc (SPPI)

[Ville]

I get the impression you are not very familiar with the 351k process. It's not like 505j or 505b2 where a simple PK can act as a bridging study. Let me just say, it's much much more complicated.

351k process? What are you talking about? eflapegrastim (Rolontis) is not developed as a biosimilar of pegfilgrastim (Neulesta). It is distinct from pegfilgrastim and so it is developed.