Replies to post #141790 on 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.

[DewDiligence]

NVS presenter at FDA FoB panel says scheduling a pre-IND meeting with FDA to discuss an FoB takes an average of 6 months (!)—much longer than scheduling a pre-IND meeting for a novel drug.

[DewDiligence]

FDA panel on FoB’s just ended—many helpful and insightful suggestions were made by the various presenters, IMO. The FDA’s docket will be open for additional suggestions until 5/23/12.

[DewDiligence]

FoB panel post-mortem: All told, there was a notable lack of interest in these proceedings on the message boards I read and on Twitter. Perhaps investors are tired of hearing about FoB guidelines and simply want to see concrete action from the FDA on specific FoB programs; on this score, the comments by NVS’ Mark McCamish (#msg-75497154) had particular relevance, IMO.

Despite the above, I did find that some of the presentations at the panel contained nuances that aided my understanding of the subject (e.g. #msg-75490408).

The biggest story of the FoB panel was undoubtedly the no-show of MRK (#msg-75491179).