Replies to post #197714 on Biotech Values

[tmoney2555]

Thanks. Would you consider this a major concern for ABBV?

[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.

[DewDiligence]

AMGN submits EU MAA for Humira FoB:

http://finance.yahoo.com/news/amgens-first-biosimilar-marketing-authorization-070000371.html

AMGN submitted a 351(k) BLA to the FDA for this product candidate on 11/25/15 (#msg-118766059).

ABBV’s ancillary patent protection for Humira is not as strong in the EU as it is in the US, so even ABBV expects FoB competition for Humira in the EU after the European CoM matter patent on Humira expires in 2018.