"We've shown this is something that has a biologicaleffect, " says Mark Tarnopolsky, a co-author of the study and a professor of pediatrics and medicine at McMaster University Medical Center in Hamilton, Ontario.
They note that it hits only one unproven mechanism behind stroke and that it may be necessary to hit multiple biological pathways to get a significant effect.
The bottom line is that for the time being, from a regulatory perspective each biosimilar version of an approved biological product will be regarded as, in effect, a completely new and distinct drug.