Biotech Values

[biomaven0]

Even though it's 100% synthetic, isn't it the case for Copaxone that (quoting from link below) "probably no two molecules are completely identical"?

So proving it's "the same" has to be challenging given there is no "same" there. Sure they can devise a bunch of tests to attempt to show it's indistinguishable from various lots of the branded drug, but given that the underlying drug is (in some real sense) impossible to characterize, will the FDA view this as enough? Maybe the next test you tried would show a difference.

I'm admittedly out of my depth here, so could well be I have this wrong.

Here's the link I mentioned above:

"The Chemistry of the Copaxone Drug"

http://www.weizmann.ac.il/ICS/booklet/1/pdf/copaxon.pdf

Peter