Biotech Values

[DewDiligence]

Re: Biogenerics vs Biosimilars / Myozyme

With the Genzyme thing, maybe I missed something, but if the FDA is taking such a strict stand that the same drug, produced by the same company, with the same process, but only at a different facility is treated as a "biosimilar" and not a "biogeneric" then what hope does such a drug, even if identical in every way, have when it is manufactured not only in a different facility, but also by a different company to be a true biogeneric?

Good question, tinker; fortunately, I have your answer. The difference in location is not the issue; rather, the FDA has taken the position that GENZ’s production process at the Framingham plant is not the same as its production process at the Brighton plant.

GENZ presumably made a number of enhancements to the production process to generate a greater yield at the Framingham plant than at the older Brighton plant. Had GENZ not done this, the FDA would not have asked GENZ to run new clinical trials to test the output from Framingham.