Replies to post #208129 on Biotech Values

[RockRat]

MNTA interchangeability: I can't tell if MNTA's switching arm was sufficient in the context of this sentence from the draft guidance:

A switching study or studies should evaluate changes in treatment that result in two or more alternating exposures (switch intervals) to the proposed interchangeable product and to the reference product.

Did MNTA switch M923 twice with Humira or just once? I can't parse that from the protocol listing or the PR.

TIA & Regards, RockRat