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DewDiligence

10/31/18 8:22 PM

#221825 RE: DewDiligence #221346

FDA approves Hyrimoz, NVS’ Humira biosimilar:

https://finance.yahoo.com/news/fda-approves-novartis-copy-abbvie-151406625.html

NVS won’t launch Hyrimoz in the US until 9/20/23, based on a recently announced patent settlement (#msg-144157243).

DewDiligence

11/30/18 10:32 AM

#222565 RE: DewDiligence #221346

ABBV settles global Humira-patent litigation with PFE:

https://www.businesswire.com/news/home/20181130005029/en

PFE’s 11/20/23 date to launch a Humira biosimilar in the US market is the same as MNTA’s (#msg-144713374), 2 months later than NVS’ (#msg-144157243), 4 months later than MYL’s (#msg-142251299), 5 months later than Samsung/BIIB’s (#msg-139804103), and 10 months later than AMGN’s (#msg-134976468).

I.e. AMGN, the first company to settle with ABBV, gets a substantial head start in the US market relative to other Humira biosimilars; ABBV’s subsequent settlements with other companies (from the second to the fifth) have successively later US launch dates, so there was a tangible disincentive to the settling companies for waiting to settle.

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In the EU, where ABBV’s Humira patents have expired (or are on the verge of expiring), the above companies can launch Humira biosimilars as soon as they have EMA approval, and some have already done so.