Biotech Values

[jq1234]

I can't understand how the FDA's statement on low volume Copaxone won't impact MNTA's generic approval.

1. FDA was talking about sNDA here, not ANDA. NDA and ANDA have completely different standards.

2. Teva applied "for its supplemental New Drug Application (sNDA) for a lower-volume (0.5mL) injection of glatiramer acetate. Copaxone® containing 20mg of glatiramer acetate in 1ml is the global market leader in the treatment of relapsing-remitting multiple sclerosis (RRMS)." FDA deemed 20mg/1mL is different from 20mg/0.5mL from NDA point of view, so adequate clinical data are needed for approval.

3. MNTA ANDA is for generic version of 20mg/1mL.