Biotech Values

[iwfal]

How would MNTA prove the generic product is identical without conducting trials?

I wasn't suggesting that they will (or won't) force MNTA to run trials - only that they will only make a decision when either forced (by court action) or when congress sets ground rules with bio-generic legislation.

As for what decision they make - I would suggest it will probably be influenced by the forcing function (e.g. if the congressional legislation doesn't have bio-equivalence as an option then I'd be more willing to bet that the FDA forces a trial.)

BTW - This isn't to say that the science isn't a factor as well (e.g. some things are easier to prove 'equivalent') but I think a significant driver of the FDA decision will be external actions.