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Re: iwfal post# 109454

Wednesday, 11/24/2010 10:15:25 AM

Wednesday, November 24, 2010 10:15:25 AM

Post# of 257253
>?? 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.

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