Replies to post #3831 on Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

It may close to impossible for other companies to produce a fully substitutable biogeneric

In the end, Biosimilar's could be made 'fully substitutable' with a stroke of the pen.

[RockRat]

Dew, you've said multiple times that Hospira's ANDA is inconsequential to MNTA investors because it aims at a tiny segment of the lovenox market. While there is no disputing the latter, if Hospira actually did get approval for this formulation, why would it stop there? If I were a Hospira exec, and my company just demonstrated the ability to meet the FDA's sameness criteria, I would go after a slice of the much bigger pie. Why could Hospira not file an sANDA, and why would it (or a new ANDA) not walk through the process easily, maybe even quickly?

TIA & Regards, RockRat