to be fair, mostly because biology/pharmacology/medicine is vexingly treacherous.
but! generics can get easy approval, they need to show that their active ingredient is the same molecule and it has a very similar biological uptake profile, and that's it (at least in Europe, but as far as I know it's very much copied from the US process)
so that's not that high bar. and of course "big pharma" knows damn well how to change just some little thing to have a different-but-same molecule but with a few more years of patent protection.
(and again, yes, it's not that the process is super duper trivially applicant friendly, but the costs in the system are not in the filing.
it's mostly because there's no real common infrastructure for the whole end-to-end iterative process. there's a lot of separate cottage industries for each step, all charging a fuckton of money, all providing mediocre services, mindboggingly shitty software for managing trials/data/patients, no incentive to improve, doc/xls based workflows, you can imagine how inefficient and slow - and thus extremely costly - these specialized services can be, etc.)
but! generics can get easy approval, they need to show that their active ingredient is the same molecule and it has a very similar biological uptake profile, and that's it (at least in Europe, but as far as I know it's very much copied from the US process)
so that's not that high bar. and of course "big pharma" knows damn well how to change just some little thing to have a different-but-same molecule but with a few more years of patent protection.
(and again, yes, it's not that the process is super duper trivially applicant friendly, but the costs in the system are not in the filing.
it's mostly because there's no real common infrastructure for the whole end-to-end iterative process. there's a lot of separate cottage industries for each step, all charging a fuckton of money, all providing mediocre services, mindboggingly shitty software for managing trials/data/patients, no incentive to improve, doc/xls based workflows, you can imagine how inefficient and slow - and thus extremely costly - these specialized services can be, etc.)