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Amgen/Allergan present Phase III data on biosimilar trastuzumab ABP 980 at ESMO 2017.

PTAB denies institution of Coherus Biosciences’ 4 IPR petitions against AbbVie’s 9,085,619 relating to the Humira® formulation.

FDA releases Form 483 raising 12 issues arising from the May/June inspections of the Celltrion Incheon biologics manufacturing facility, where Celltrion and Pfizer/Hospira’s biosimilar Inflectra® (infliximab-dyyb) is made.

FDA extends its decision deadline by 3 months on a s351(k) application for MYL-1401O, Mylan and Biocon’s trastuzumab (Herceptin) biosimilar.  Final decision is now expected by 3 Dec 2017.

Samsung Bioepis has filed three petitions seeking joinder with Hospira’s IPR against key Genentech trastuzumab patents (IPR2017-01958 against 6,627,196 patent; IPR2017-01959 against 7,371,379, and  IPR2017-01960 against  7,892,549).  Hospira’s petitions against the same pat...

Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for Cyltezo® (adalimumab-adbm), a biosimilar to Humira®.  This is the first biosimilar from BI to be FDA approved.  According to the release:

Cyltezo® is not yet commercially available due to the act...

Imraldi®, Biogen/Samsung’s adalimumab biosimilar approved in the EU.