Replies to post #70517 on Biotech Values

[DewDiligence]

Re: MRK’s ‘FoB’ program (addendum)

FDA is going to require clinical trials for fob's, even if you claim to be making exact replicas.

That’s not the point; rather, the point is whether the FDA will require a full fledged clinical program or an abbreviated clinical program that relies in part on the clinical data for a reference drug.

If the latter, it’s an FoB; if the former (what MRK is talking about), it’s simply a branded biologic for an established target.

[genisi]

I think we all agree that there won't be an automatic substitutability and some clinical trials will be required. The uncertainty is about what size&type of studies. Although a regulatory pathway requiring an abbreviated application is still a possibility, I think that for many Fob's phase III shaped studies would likely be needed to demonstrate therapeutic equivalence to the reference product.