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