Biotech Values

[biomaven0]

deemed fully-substitutable

I really see no basis for an approval on a not fully-substitutable basis. The FDA by doing this would be saying "it's sort-of the same" and if they do that they have no real basis for claiming equivalent safety and efficacy. There is no comparable situation where they have ever done this before - I believe the existing non-AB generics were all designed to be different than the originals in some way (dosage form, PK, etc.).

To my mind it's either a full approval in the near term or a significant delay (longer than a year) before approval.

Peter