Biotech Values

[stockdak]

GENZ/GTCB and FOBs

Because GTCB's production platform produces proteins with altered carbohydrate patterns than native human proteins doesn't this Myozyme ruling speak volumes for the FOBs (like CD20) that GTCB has in development? I take this to mean that GTCB would need to perform complete trials and NDA for their FOBs (i.e they could not use the generic ANDA mechanism). Has this always been the assumption?

I do see the reasoning behind this approach from the FDAs point of view. The proteins are different. The interesting question is how different are they functionally or in their immunogenicity?

From what I understand even though Atryn is different in terms of its carbohydrate pattern from the native protein the bioactivity is the same and the it has not stimulated an immune response in any patient to date.

I wonder how many cases this has to be shown before less regulatory rigor is required?