Replies to post #17886 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

Re: Generic Copaxone in EU

Doesn't make sense how it is not viable for Momenta/Sandoz in EU while Mylan/Synthon and Teva are able to reap profits. …if Sandoz isn't going to pursue EU, why not partner with someone else?

Copaxone in the EU is a business proposition that is not worth pursing for MNTA because the expenditure on clinical trials would outweigh the potential profits.

Unlike the US, the EU regulates Copaxone as a biologic. Hence, “generic Copaxone” products in the EU are not substitutable generics as in the US market, but rather are distinct branded products that require their own clinical dossiers for regulatory approval.