Biotech Values

[DewDiligence]

HSP’s speaker at the FoB panel proposes that separate immunogenicity testing not be required prior to product approval. His implicit argument is that a highly similar product is very unlikely to cause immunogenicity not seen in the corresponding branded drug unless there is something seriously wrong with the FoB’s manufacturing process.

Moreover, ascertaining the frequency of low-frequency events such as immunogenicity in a trial that does not consume an inordinate amount of time and expense is difficult to accomplish, and hence requiring such a trial is at odds with the economic impetus for FoB’s. Immunogenicity of an FoB should therefore be tracked on a post-marketing basis.

I think these are good points.