Replies to post #92900 on Biotech Values

[dewophile]

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

the same way any generic small molecule company does - by showing that the generic contains the identical API. I agree this is more difficult than lovenox in that you don't know the MOA, have no in vitro diagnostic tests to measure activity like you do with lovenox (anti Xa/IIa activity),...BUT i also don't think it is quite the same level of complexity as traditional biologics that have both protein and sugar moities. in fact, for glycoproteins, proving the AA backbone of the structure is the easy part, but the variability in glycosylation between cell culture systems is what introduces the variability to make it more difficult to prove sameness without trials. Here you don't have that problem - so even though it is a mix of peptides, i think if you can show that you have the identical mix in the soup one can assume activity is the same because you don't have the difficulty in proving glycosylation patterns won't affect the activity of the final product

[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.