Replies to post #100020 on Biotech Values

[RockRat]

"An ANDA applicant would not need to know Aventis' exact manufacturing process parameters and conditions (e.g. depolymerization time, pH, and temperature) to manufacture the same active ingredient as Lovenox's enoxaparin" The footnote to this statement reads "As a general matter, manufacturing information is considered confidential commercial and/or trade secret information, which cannot be disclosed by the agency."

If immunognenicity data is also considered confidential, I don't know how the FDA handles the Chinese wall aspect of the comparative assessment. I would imagine the applicant submits the data, and the FDA says "good enough" or "not good enough." Or the FDA could set targets that are not exactly the same as what the pioneer's drug achieved, but rather within generally accepted norms. Surely such issues have been dealt with many times.

What I'm saying is that the FDA relies on confidential information for comparative assessment, not the generic applicant. I'm going to figure that the FDA did something like that, and it will come out in deposition that they did not improperly reveal any trade secrets in the process.

Edit: I see Peter put this in simpler terms.

Regards, RockRat

[poorgradstudent]

>I believe that SNY is arguing that this kind of "comparative assessment" is prohibited by FDA statutes.<

Do we know that the data submitted by MNTA pertained to their product only? Seems to me that the way for MNTA to do these comparisons is to check their product versus commercially available Lovenox. Otherwise, they would not be able to say "our generic product X is within the range demonstrated by brand drug Y."

If all the data submitted to the FDA were provided by MNTA, then it wouldn't be a breach of anything.