Biotech Values

[DewDiligence]

(MNTA)—I have to check, but I don’t think other companies developing Humira FoBs have included switching in their phase-3 studies.

AMGN, the only company with an FDA-approved (but not yet launched due to litigation) Humira FoB, did not have switching arms in either of its phase-3 studies: one in RA (https://www.clinicaltrials.gov/ct2/show/NCT01970475 ) and one in psoriasis (https://www.clinicaltrials.gov/ct2/show/NCT01970488 ).

For companies seeking biosimilar—but not interchangeable—FDA status, conducting clinical trials with switching adds time, expense, and risk to the program without a clear commercial upside even if it works without a hitch.