FDA approves biosimilar of blockbuster Humira

A Humira biosimilar, produced by drug maker Sandoz, has been given the green light from the US Food and Drug Administration (FDA).

Sandoz, a division of Novartis, confirmed that the FDA granted approval for its medicine Hyrimoz (adalimumab-adaz).

The drug can be used to treat rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

Adalimumab, the active ingredient in Hyrimoz, inhibits the tumour necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions, as mentioned above.

The medicine targets and blocks the protein that contributes to disease symptoms.

Stefan Hendriks, global head of biopharmaceuticals, Sandoz, said: “Biosimilars can help people suffering from chronic, debilitating conditions, gaining expanded access to important medicines that may change the outcome of their disease.

“With the FDA approval of Hyrimoz, Sandoz is one step closer to offering US patients with autoimmune diseases the same critical access already available in Europe.”

Despite the approval, US patients must wait until the US patent on Humira expires on September 30, 2023, at which time Hyrimoz can be legally prescribed.

Meanwhile, the EU patent for AbbVie’s Humira, which is the world’s bestselling drug, expired last month, prompting other pharma companies to push their biosimilar versions of Humira on to the market in Europe.

As pharmaphorum reported, sales of Humira hit the $4.4 billion mark in Europe at the end of June this year, according to healthcare data firm IQVIA.

There is a pressing need for the NHS to save money on its prescribing budget, making the availability of biosimilars key. Humira costs the NHS more than £500 million a year.

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.

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

Sandoz has stockpiled adalimumab so that patients will be able to access their medication in the event of a no-deal Brexit. Negotiations between the UK government and EU are still ongoing, more than two years after the referendum.