Replies to post #101763 on Biotech Values

[bladerunner1717]

Dew,

Do non-substitutable generics always require a clinical trial?

What are the criteria that the FDA uses to differentiate a substitutable from a non-substitutable generic?

How do you refer to a drug that is a non-substitutable generic? In other words, what is the correct terminology to distinguish a substitutable from a non-substitutable generic?

If a ocmpany applies to be a substitutable generic, but the FDA says it is not substitutable, does the FDA then use another pathway to approve (or not approve) the drug?



Bladerunner

[Mpower]

That would be highly unlikely in light of tevas response to news of momenta's mL approval.