MNTA does not yet have any FDA-approved FoBs. MNTA's most advanced FoB program is M934 (Humira), where the FDA submission is expected in mid 2017 (#msg-128817210).
MNTA has FDA-approved generic versions of two drugs—Lovenox and Copaxone—that are complex substances regulated as biologics in most of the world; however, the FDA treats Lovenox and Copaxone as non-biologics, and hence these approvals came under the ANDA pathway for small-molecule drugs.
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