Biotech Values

[DewDiligence]

>It would be interesting if immunogenicity data will have to be collected for all potential generic drugs submitted via an ANDA.<

I assume you mean generic drugs that are complex mixtures, as Lovenox is. It would hardly make sense for the FDA to ask for immunogenicity data in a typical ANDA. (Nor does the OGD section of the FDA need an excuse to increase its workload!)

>wow, MNTA first filed the ANDA in August of 2005, and this is the first time the FDA mentioned immunogenicity?<

Teva and Amphastar field their generic-Lovenox ANDA’s in 2003.

>…does it always take this long for generics to be reviewed?<

No.