Biotech Values

[DewDiligence]

SNY is standing Hatch-Waxman on its head:

The key argument by SNY is that the case and law permit the FDA to consider [immunogenicity] testing if voluntarily submitted but that the FDA may not require such testing.

As biomaven noted in a prior thread, the intent of this provision in Hatch-Waxman Section 505(j) is to facilitate rather than hinder FDA approval of generic drugs. Thus, this H-W provision could have formed a basis for NVS/MNTA to have sued the FDA if their ANDA had been rejected on the basis on immunogenicity.

For SNY to argue against FDA approval of generic Lovenox because the FDA asked for immunogenicity data is tantamount to standing this H-W provision on its head, and I expect that the Court will so rule.