>MNTA – I was interested in the part of the presentation where the possibility of legislation enabling interchangeability with a branded drug was discussed, as part of an overall FoB Congressional bill. It sounds, again, as if MNTA has been actively lobbying the FDA towards this goal.<
They presumably are lobbying. If Congress were to pass an FoB deal that explicitly precluded substitutability, it would be a major blow to MNTA. However, I think such an outcome is unlikely.
The more likely outcome—one that would work well for MNTA—is an FoB framework where the FDA has the authority to approve either a full-fledged substitutable generic or a non-substitutable biosimilar, much like the 505j and 505b2 pathways for small-molecule drugs, respectively.
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