Replies to post #109454 on Biotech Values

[floblu14]

>?? I haven't seen any such credible/defensible argument put forth by anyone?<

From DD - March 22 '10

MNTA:
Quote:
…characterizing a mix of polypeptides is easier than sugars

Absolutely correct. Because it’s 100% synthetic and has no biologically sourced API, Copaxone is easier than Lovenox to reverse engineer to the lot-to-lot tolerance of the branded product.

If the FDA approves generic Lovenox via the 505j (ANDA) pathway, generic Copaxone ought to be no problem for MNTA, IMO.

[DFRAI]

iwfal

MNTA is able to copy copaxone and characterize the entire structure. Why did FDA approve teva's copaxone if they did not know the MOA?
Why should FDA carry about MOA when MNTA will copy the strucutre and deliver sameness - hence a fully substitutable generic?????????????????????????????????

[genisi]

I don't think Copaxone is easier to replicate not only chemically but also to show equivalence. However, I do believe Momenta has the technology. Problem will be to convince the FDA they have good enough data and/or the right assays.