Biotech Values

[DewDiligence]

>MNTA …when it comes to a fundamental change in a product from its native form, which cleaving a carbohydrate constitutes, screening for immunogenicity should be a no-brainer<

You’re still talking as though this was a new drug application rather than an ANDA. FDA regulations state that the requirement for approval of an ANDA is that the generic product be chemically identical to the branded product, and MNTA contends that it is.

Whether the immunogenicity issue is a red herring (as I speculated in #msg-24307629) or a genuine medical concern will become clear in due course, but I’ll be surprised if generic Lovenox induces greater immunogenicity than Lovenox itself.