Biotech Values

[DewDiligence]

AMGN submits 531(k) BLA for Humira FoB:

http://finance.yahoo.com/news/amgens-first-biosimilar-biologics-license-210000031.html

This is AMGN’s first 531(k) submission and the first publicly-disclosed 531(k) submission for Humira. AMGN’s commercial partner on this program is AGN (originally Watson).

Being the first applicant for a Humira FoB in the US market, AMGN will presumably become the first target for a lawsuit by ABBV claiming infringement of formulation and method-of-use patents (#msg-118144295), although ABBV might wait until AMGN receives FDA approval before filing suit.

Other companies pursing Humira FoBs—including PFE and BXLT/MNTA—will be paying close attention to the ensuing litigation.