Hi Mozzarc,
I don't really know enough about it to make any very useful comment, except that I'm still a bit sceptical as to the claim that PPS is so much harder to replicate than any other off-patent drug that a pharmaceutical company that wants to make a generic version of.
I can understand why they would say that though.....
PPS is pretty much a niche drug at the moment, with only, I think, about 600 prescriptions written in Australia last year, so presumably nobody's going to be very interested in spending mega-bucks replicating an existing facility by reverse engineering the whole thing for such a small market. But as to whether that will still hold true if the whole thing takes off as we hope, only time will tell.....but I assume Bene are planning to ramp up production by about 10000% if everyone in the world with a bit of OA is looking for a script from their GP.....
My view is that PAR is very much a window of opportunity/first mover advantage play, so let's hope they can spin it out for as long as possible.
FYI this seems to be the definition of bio-equivalence (lifted off the Internet)
Theabsence of a significant difference inthe rate and extent to which the active ingredient or activemoiety in pharmaceutical equivalents or pharmaceuticalalternatives becomes available at the site of drug action when administeredat the same molar dose under similar conditions in anappropriately designed study.
Cheers
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