Biotech Values

[DewDiligence]

AMGN’s 531(k) BLA for Humira FoB is potentially good news for HALO.

The ensuing litigation between AGMN and ABBV will answer, in due course, the question of whether ABBV’s ancillary Humira patents can keep Humira FoBs off the US market until 2022 (as ABBV claims), or whether these patents lack enforceability, allowing Humira FoBs to enter the US market much sooner (#msg-118766059).

In the latter case, ABBV would presumably rely on its HALO-derived reformulation of Humira to a larger degree than if the ancillary Humira patents were to stand up to challenge.