Replies to post #120738 on Biotech Values

[DewDiligence]

RLD claims average molecular weight range. Generic product in order to prove its equivalence will need to show their generic falls within the range of average mol weight as specified in RLD.

As noted in #msg-63695268, NVS/MNTA’s production process is not based on a predetermined* average molecular weight. This does not imply that the outcome of the process has an average molecular weight that differs from branded Copaxone.

*The word predetermined is highlighted with italicized text in NVS/MNTA’s legal pleadings.