Re: Biogenerics, Congress, and the FDA
>…it will take a long time for the FDA to establish guidelines for biogenerics, but they are working on it.<
The FDA could create workable guidelines for biogenerics right now, and Janet Woodcock has already stated this. What the FDA needs is enabling legislation from Congress. In other words, the issue is not scientific—it is political.
>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.<
If Congress passes a sensible law, the FDA guidelines will be flexible to take into account the complexity of a given protein drug and the ever-improving analytical technology to characterize such a drug.
>Making a biogeneric version of a peptide should be much easier for several reasons.<
Peptide drugs (e.g. Copaxone) are currently regulated as small molecules. Hence, full-fledged, substitutable generics for these kinds of drugs can be approved with the FDA’s existing ANDA process, provided that an applicant demonstrates that the generic is identical to the branded drug though full characterization.
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