Replies to post #111960 on Biotech Values

[acgood]

The brief answer is, based on the US and EU guidelines, NO.

[DewDiligence]

For a [Rituxan] biosimilar, will it also need ph-3 trials in each of the NHL subindications to get approval in those area? …i have that general question about biosimilars?

Great questions. A successful trial for a Rituxan biosimilar in one of NHL indications where Rituxan is approved should be sufficient for the biosimilar to be FDA-approved in all NHL indications where Rituxan is approved as well as in indications such as CLL that are closely related to NHL. However, I use the word should in the above sentence because the way the FDA will answer your question is not crystal clear.

For biosimilars in general, the more closely related the set of indications are, the greater the probability that a successful clinical trial by a biosimilar in one of the given indications will confer approvability of the biosimilar in related indications without the need for distinct clinical trials in the other indications.

Until the FDA makes its requirements concrete, common sense can help guide investors. For instance, a successful trial by a biosimilar in a cancer indication probably won’t carry over to autoimmune indications, and vice-versa. However, a successful trial in one autoimmune indication such as RA will likely carry over to another autoimmune indication such as psoriasis.

[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.