Replies to post #16393 on Momenta Pharmaceuticals, Inc. (MNTA)

[indigokid]

Despite the multitude of Humira biosimilars in the pipeline and the general lack of clarity on those applications, but after re-reading the draft guidance the early articles and comments -- I am going out on a limb and predicting that MNTA will be granted the first AB rated interchangeable Humira.

[DewDiligence]

Initial feedback to FDA’s draft guidance on interchangeable FoBs is coming in:

#msg-130177707

The deadline for submitting comments is 5/19/17.