>I think the downside from biogenerics is going to be more pervasive than most AMGN investors probably do.<
and from another post:
>Many investors seem to think Big Biotech will be able to block biogenerics indefinitely, but I’m pretty sure they are wrong.<
Do you really think "many investors" think this? Yes, it will take a long time for the FDA to establish guidelines for biogenerics, but they are working on it. I suspect the guidelines will include more extensive clinical trials than "traditional" generics do. I think it will take more than PK/PD data, especially for larger proteins.
For example, generic antibodies may be the easiest thing to produce in the same manner as branded ones, but unless you get ahold of the DNA that codes for the antibody's binding region, you may have an antibody that binds to a given target in a slightly different fashion. Sometimes even a slight difference matters. Iressa and Tarceva are small molecule examples of this.
Making a biogeneric version of a peptide should be much easier for several reasons.
Plus, changes in patent laws to avoid frivolous patents (e.g., tightening the "obviousness" clause) could drive big pharma towards biogenerics. Big pharma and biotech have well financed lobby groups that could duke it out on this issue.
The generic industry will too.
