Biotech Values

[DewDiligence]

Do you feel that some day interchangeability can be established without any clinical data?

When companies tweak the production process for a branded biologic, they usually do not have to run new clinical trials to obtain FDA approval (although they occasionally do, e.g. with GENZ’s Myozyme/Lumizyme). I think the FDA will treat FoB’s that are extremely well characterized in a similar manner to the way they treat minor production changes to branded biologics.