Challenge to UK Humira patent begins

Samsung Bioepis’ legal challenge to patents on AbbVie’s blockbuster Humira is beginning in the UK Patent Court, which could pave the way for cheaper biosimilars to be marketed from 2018.

The legal case, which is also backed by Biogen, will attempt to clear a thicket of patents surrounding Humira (adalimumab) aimed at preventing competition from biosimilars from the Samsung/Biogen joint venture and other challengers.

Fujifilm Kyowa Kirin Biologics will also be taking on AbbVie in the trial.

The hearing could last as long as two weeks, and will be keenly watched as it could see Humira will face biosimilar competition earlier than expected.

Humira is the world’s biggest selling drug with sales topping $14 billion worldwide in 2015, with around $5.6 billion coming from sales outside the US. Much of this ex-US revenue came from Europe.

Humira’s main European patent expires in October next year and Samsung Bioepis’ biosimilar is under review by European regulators after a filing last summer.

According to a report in the Korea Herald, AbbVie asked the companies to drop their litigation, in return abandoning rights to the patents they were challenging. But the challengers did not accept this in case AbbVie filed new, similar patents shortly afterwards.

Amgen is also among the companies aiming to launch a biosimilar of Humira – its biosimilar is already approved in the US but cannot be launched because of patent restrictions.

AbbVie’s CEO, Richard Gonzalez said at last week’s JP Morgan Healthcare Conference in San Francisco, that sales of Humira could exceed $18 billion worldwide by 2020.

In the US, Gonzalez said that AbbVie could hold off biosimilar competition until 2020. No one from AbbVie was immediately available for comment on the case.

A Samsung Bioepis spokesperson, Mingi Hyun, said in a statement: "We took this action to ensure our affordable, high-quality biosimilars will reach the patients who need them most. We believe that AbbVie has been attempting to obstruct the market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable, high-quality medication."