Biotech Values

[DewDiligence]

MNTA’s phase-3 trial for Humira FoB had FDA–mandated switching:

Consistent with the draft FDA guidance on interchangeable FoBs that requires switching patients back and forth between the branded drug and the FoB without clinical harm (#msg-127909952, #msg-127915407), MNTA’s phase-3 trial for M923 (its wholly-owned Humira FoB) had a switching arm—the third arm in the clinicaltrials.gov listing:

https://www.clinicaltrials.gov/ct2/show/NCT02581345

The use of switching was also confirmed in MNTA’s 11/29/16 PR (link in #msg-126858164):

This was a confirmatory, randomized, double-blind, multicenter study evaluating the efficacy, safety and immunogenicity of M923 in adult patients with moderate-to-severe chronic plaque psoriasis. Patients received up to 48 weeks of treatment with M923, HUMIRA, or HUMIRA alternating with M923 [emphasis added].

So, it would appear that MNTA is all set wrt the switching requirement in the new FDA draft guidance.