Biotech Values

[DewDiligence]

Answer to FoB quiz in #msg-72306361: In response to the BioCentury interviewer’s question about whether an FoB will receive a label with all of the indications of the corresponding branded drug (a topic previously discussed on this board—e.g. #msg-58469454), the FDA’s Dr. Sherman said that it would generally be appropriate to “extend” the label of the FoB from indications representing more severe disease to those representing less severe disease, but not vice-versa.

Then, later in the same interview, Dr. Sherman cited a hypothetical example in cancer immunotherapy that contradicted the above policy, saying that it would be inappropriate to extend the label of the FoB from patients with advanced disease to those with less-advanced disease because the latter patients have stronger immune systems and are more likely to encounter undesirable immunogenicity.