Biotech Values

[dewophile]

I think this WSJ article puts everything into context. Teva stated on its latest Teva earnings call said that it was told by the FDA that it achieved "sameness". According to Amphastar it was told in late 2007 that it met the standards for "sameness". So IMHO Teva's was just repeating what the FDA stated to them in 2007 before MNTA changed the standards.

this may be correct, although teva did mention that the "chemical sameness" was established "recently"

here is from the prepared remarks:

"We recently met with representatives from the FDA to discuss the status of our ANDA. During the meeting, we confirmed that our version of generic Lovenox meets the FDA's criteria to demonstrate chemical sameness"

so i have to think they came away from the october meeting with this understanding from the FDA. that said i am in the camp that feels that given the very specific nature of the term used - "chemical sameness" - it is most likely referring to the 5 criteria in which "chemical sameness" is mentioned under criteria #1 to describe the active component, and this does not necessarily mean that teva has met the other 4 criteria

on a side note approving teva and/or amphastar soon would lend credence to the notion that all 3 generics are approvable and the FDA did show favoritism towards momenta by giving them the green light first with some nice exclusivity period despite their application coming 2 years after teva/amphastar (i.e at this point they are best served sticking to their guns that the other applications are simply deficient lest they add fuel to this fire from the GAO report)
jmo