Samsung targets Humira patent thicket with UK lawsuit

Samsung Bioepis is taking AbbVie to court to challenge patents which prevent a biosimilar version of Humira (adalimumab), the biggest selling drug in the world.

The lawsuit was filed late last month in the UK, and the biosimilars company told pharmaphorum that the action will target a thicket of patents that AbbVie has put up around the drug, which earned over $14 billion worldwide in 2015. $5.6 billion of this was earned outside the US, with much of this revenue coming from Europe.

Humira’s main European patent expires in October 2018 and Samsung looks on course to have a biosimilar rival ready around this time.

Samsung is developing its Humira near-copy with Merck & Co, which succeeded in a phase 3 trial last year that compared it to the originator drug.

A spokesperson for Samsung said: “We believe that AbbVie has been attempting to obstruct market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable medication.”

No-one from AbbVie was immediately available for comment.

Samsung’s biosimilar of J&J/MSD’s Remicade (infliximab) received the green light from European regulators last week, paving the way for a launch in the coming months in the likely event of final approval by the European Commission.

Its Benepali (etanercept), a near-copy of Amgen’s rheumatoid arthritis drug, Enbrel (etanercept) was approved in January by the European Commission.
Biogen, Samsung’s partner in Europe, is already marketing and distributing Benepali and will also market and distribute Flixabi should it receive final approval.

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