Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

Re: FDA’s draft guidance for interchangeable FoBs

• MNTA’s phase-3 trial for Humira FoB had FDA–mandated “switching” (#msg-127945401), so MNTA is all set on this score.

• That fact that FDA interchangeable FoBs can be approved in a single review (rather than a two-step process as the FDA had originally hinted) is perhaps the biggest positive for MNTA in the new guidance.