One other comment about Sanofi's position, at least as it relates to the cited article, in which the article cites Sanofi as stating that it is not possible to fully characterize the drug molecule by molecule. First, this position is very bullish for MNTA who can do this better than anyone else, and in fact claims that they have.
Second, if the judge rules for Sanofi (despite already tacitly admitting, and Sanofi doing the same) that m-enoxparin is not dangerous (and danger also means does not work as represented) the court will be setting a standard that is so high that no one will be able to create generic biological drugs. And the court is simply not going to do this. A generic has never had to copy molecule by molecule the innovator product, and the same will be true here.
But Sanofi's position is the one that MNTA would be taking if Teva's product were accepted on lessor characterization than MNTA managed, except without the immunogenicity issue.
MNTA would have a better case on this score than Sanofi does on its present count. I am not making any opinion that MNTA would so sue the FDA on this ground, or that it would even have the grounds to do so. Just using it as comparison to better illustrate the Sanofi case and what it may mean.
Tinker
AI
