Biotech Values

[DewDiligence]

(MNTA)—Nothing in Synthon’s PR alters the commentary in #msg-99508291 or tells investors whether Synthon has reverse-engineered branded Copaxone to the satisfaction of the FDA.

Synthon’s clinical data may help Synthon get approval as a biosimilar in the EU; however, the FDA regulates Copaxone as a small-molecule drug, and hence safety and efficacy data are not the ticket to approval as a 505(j) substitutable generic.