(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.
This has no material effect on MNTA insofar as the NVS/MNTA collaboration was not planning to develop a Copaxone FoB for the EU.
Three adversaries were cited in Teva’s PR: Synthon, MYL, and an unidentified party. The EPO decision most directly affects Synthon insofar as the EU was the main target market for Synthon’s Copaxone knockoff (#msg-99563993).
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