Biotech Values

[DewDiligence]

If the FDA has truly acknowledged "sameness" according to the five criteria as Amphastar claims, then Teva's claim to have achieved sameness must also get a boost in credibility.

The five criteria for approval set forth in the FDA’s response to SNY’s CP were not even codified in Nov 2007, when Amphastar claims to have been told it had achieved sameness. Therefore, a reasonable interpretation of events is not that Amphastar and Teva are close to approval, but rather that chemical sameness is not a consequential achievement.