Biotech Values

[RockRat]

For those of us interested in further drilling down into the bioequivalence aspect --from a regulatory perspective -- of both Teva's application and Sanofi's lawsuit, here is some language from the Code of Federal Regulations that addresses it. Note that these regs came to be in 2005. Also, note the section on impurities and different inactive ingredients.

http://cfr.vlex.com/vid/314-94-content-abbreviated-application-19710127

It is not clear to me that an applicant would have to refile each time it submits an improved version of the drug it's trying to copy. Not sure how much difference it makes, since ANDA filings can be secretive, anyway.

Did someone already post the Serono vs Shalala ruling regarding pergonal (My user level does not allow a search; I know I saw it somewhere)? Sorry, if so. Anyhow, it would seem to support the idea that the Sanofi lawsuit won't get far. It also addresses uncharacterized inactive ingredients.

http://vlex.com/vid/serono-shalala-ferring-pharmaceuticals-18764119

The parallels are huge.

Regards, RockRat