Replies to post #100009 on Biotech Values

[bladerunner1717]

The counter argument would be:

'Of course, "Verification of manufacturing purity is a regular feature of generic-drug applications..." but not by way of "in vitro immunogenicity data." The FDA was clearly looking for data on safety and efficacy.'


Bladerunner

[RockRat]

" I would characterize the FDA’s request for in vitro immunogenicity data as a way to verify the manufacturing purity of NVS/MNTA’s drug."

It's not that plain, IMO. Human safety and manufacturing purity seem to be pretty well conflated here. Look at the response to the CP:

"It is important that ANDA applicants assess the potential to generate a greater immune response as compared to the RLD, Lovenox." Top of page 4. Concern about immune response is not solely a manufacturing concern. In vivo tests were done, by the way. See page 41 -42. Anyhow, I think that given the wording in the CP, it could be construed both ways.

Whatever, as I posted elsewhere, I fail to see how Sanofi was negatively affected by this request. I don't see how any of their confidential commercial information is affected by it. As such, it is not they who have standing or were harmed by this request, it is the generic applicants. Sanofi actually benefitted from the delay caused; they should be friggin' grateful. Unless I'm missing something about this aspect. Wouldn't be the first time.

Regards, RockRat