Biotech Values

[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.