Replies to post #15544 on Momenta Pharmaceuticals, Inc. (MNTA)

[Boing x 2]

DewDiligence,

I agree.

I was being very careful on any FDA discussions. I alluded to the fact the FDA might be coming around to our way of thinking as they already have the molecules tied down upon any submission. It would reduce development costs to not have to wait years.

Boing X 2

[indigokid]

I agree this is pretty significant - especially for MNTA.

While extremely subtle It may again show how impressed the FDA is with MNTA's analytics as their thinking evolves in the evaluation and approval of generic biologics under the 351(k) pathway.

Although, not likely to affect other biosimilar players nearly as positively IMO since MNTA has been the only one that has articulated and pursued a "bio-same" with "fingerprint" similarity and fully interchangeable strategy in contrast to just a "bio-similar" generic strategy (similar to the traditional compounds business) pursued by almost all other players.

While still early to draw meaningful conclusions it would seem that though Novartis was first out of the gates with an approved biosimilar its uptake has been less than stellar - likely because its not rated as interchangeable....so the just generic biosimilar strategy may not prove to be the winning formula in approaching the complex biologics generics business.