Billions up for grabs as EU patent on AbbVie's Humira expires

The patent for Humira, the world’s bestselling drug, expires in Europe today – opening the door for a host of cheaper biosimilars to hit the market.

Sales of AbbVie’s Humira (adalimumab) reached $4.4 billion for Europe at the end of June this year, according to healthcare data firm IQVIA. This represents a huge opportunity for companies hoping to step into the blockbuster’s shoes.

Crucially, Humira costs the NHS more than £500 million a year, a sum that NHS England wants to see fall through biosimilar use.

Sandoz is one such company that hopes to offer the NHS savings potential. Its Humira biosimilar, Hyrimoz, could represent savings of more than £250 million a year, according to the company, which is a division of Novartis.

Kavya Gopal, head of speciality business at Sandoz UK said: “Now that doctors can prescribe Hyrimoz, Sandoz's biosimilar adalimumab, the NHS has the opportunity to increase patient access to biologic treatments. As we’ve worked to launch Hyrimoz as the Humira patent expires, the NHS can start saving money from today.”

The approval of Hyrimoz was based on a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that the biosimilar matched the reference medicine in terms of safety, efficacy and quality.

Sandoz says it has stockpiled supplies of adalimumab so that in the event of a no-deal Brexit, patients will not be denied medicine.

Several companies have produced biosimilar versions of Humira. Fujifilm Kyowa Kirin Biologics granted Mylan an exclusive licence to commercialise its version of adalimumab, Hulio, in Europe.

Amgen, Biogen and Samsung Bioepis have all have been granted European regulatory approval for their Humira substitutes, too, alongside Sandoz.

Amgen’s version, Amgevita, was the first adalimumab biosimilar to be approved by the European Commission (EC).

David Reese, executive vice president of R&D at Amgen, said: “The launch of Amgevita in Europe is an important milestone for our biosimilars portfolio, expanding the range of treatment options for the millions of patients living with chronic inflammatory diseases.”

Boehringer Ingelheim, according to a report in the Financial Times, is locked in ongoing litigation with AbbVie and, to date, has no plans to launch its already-approved Humira biosimilar in Europe.

The monoclonal antibody is used to treat immune conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis.

Humira is patent protected in the US until 2023, where the majority of its sales are based.