Biotech Values

[gfp927z]

Dew, Wouldn't some degree of efficacy/safety testing be only prudent for generic copies of complex structures like MABs, proteins, complex carbohydrates, etc?

It wouldn't be surprising to ultimately see clinical trial requirements for biogenerics, especially since the FDA is now so safety conscious. Momenta's drug is in a grey area though, since it's very complex structurally but isn't produced in a living organism. It sounds like the FDA hasn't yet decided how they're going to deal with this whole area, thus their caution/delaying tactics.