Replies to post #196660 on Biotech Values

[DewDiligence]

MRK/Samsung/BIIB—Phase-3 data on Humira FoB will be presented at ACR:

http://finance.yahoo.com/news/merck-announces-samsung-bioepis-present-134300604.html

SB5 Humira (adalimumab) data at ACR

Abstract # 8L – Late-Breaking Poster Presentation: A Phase III, Randomized, Double-Blind Clinical Study Comparing SB5, an Adalimumab Biosimilar, with Adalimumab Reference Product (Humira) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: 24-Week Results; Tuesday, Nov. 10, 9:00 – 11:00 a.m. PST

[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.