Samsung Bioepis' Humira biosimilar launches in EU

Samsung Bioepis has become the latest biosimilars company to confirm it has launched a cheaper near-copy of AbbVie’s Humira inflammatory diseases blockbuster, after its European patent expired this week.

The launch means the South Korean company now markets biosimilars of the three most commonly prescribed anti-TNF drugs – Amgen/Pfizer’s Enbrel (etanercept), Johnson & Johnson/MSD’s Remicade (infliximab), and Humira.

But Humira is the most commonly prescribed of the three drugs, thanks to a raft of approved indications, and is the most costly to the NHS.

A joint venture between Biogen and Samsung, Biogen will market the Humira biosimilar, branded as Imraldi, in Europe.

Dan Cohen, regional director of Biogen UK, Ireland and Netherlands, said: “With the addition of Imraldi to our anti-TNF biosimilar offering, we are increasing clinician choice and patient access in the UK to affordable treatments across disease areas.”

Imraldi is approved for rheumatoid arthritis, two forms of juvenile idiopathic arthritis, axial spondyloarthritis, including ankylosing spondylitis (AS), axial spondyloarthritis with radiographic evidence of AS, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and uveitis.

A host of other biosimilars firms have also got Humira competitors approved, hoping to steal market share from AbbVie, which enjoyed revenues of $4.4 million from Humira up to June this year according to figures from IQVIA.

Novartis’ biosimilars and generics arm Sandoz launched its Humira biosimilar yesterday, along with Amgen. Sandoz says it has stockpiles of the biosimilar in event of a no-deal Brexit.

Fujifilm Kyowa Kirin Biologics granted Mylan an exclusive licence to commercialise its version of adalimumab, Hulio, in Europe.

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.

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