Biotech Values

[DewDiligence]

why are they saying the proposed generic's avg mol weight or peak mol weight does not conform to within claimed ranges of branded drug copaxone? If so, how will this product be considered equivalent by FDA?

The answer to your question is in the other bulleted items on the same page:

It is not possible to determine the molecular weight of individual polypeptides or “species” of Sandoz’s proposed product (see Plaintiffs’ Response to Defendants’ Statement of Material Fact paragraph 60).

...Sandoz’s proposed product does not include a “predetermined molecular weight profile” or “reacting protected copolymer-1 with hydrobromic acid…for a time and at a temperature predetermined by test reaction.