Another Humira biosimilar hits EU shores

Samsung Bioepis has announced the European launch of Humira biosimilar Imraldi, as NHS chiefs tell Trusts to ensure they are ready to realise the potential savings from using cheaper versions of the world’s biggest selling drug.

Doctors in the UK will be able to prescribe Imraldi for any of Humira’s approved indications, which include the treatment of rheumatoid arthritis (RA), psoriasis, hidradenitis suppurativa and Crohn’s disease.

According to the firm, Imraldi has shown equivalent pharmacokinetics and efficacy as well as comparable safety and immunogenicity to its reference drug, “whilst offering a greater shelf life of three years compared to two years for Humira,” and a cheaper price tag.

“We look forward to increasing patient access to this important medicine by leveraging our industry-leading position in the European anti-TNF market,” said Ian Henshaw, head of Biogen’s Biosimilars Unit.

The moves comes just a day after NHS chief executive Simon Stevens called on NHS hospitals to ensure they are ready to realise savings of up to £150 million a year to reinvest in frontline care, following the end of the patent for Humira.

Humira is the single medicine on which hospitals spend the most, at a cost of more than £400 million a year.

NHS England has now issued guidance to Trusts and CCGs telling them that nine out of 10 new patients should be started on the best value medicine within three months of a biosimilar launch.

At least 80% of existing patients should be switched to the best value biologic (which could be the originator or a biosimilar) within 12 months, it says.

“Biosimilar versions of widely used, expensive drugs are already delivering safe, effective treatment for patients across the NHS, including those with cancer,” Stevens noted.

“Adalimumab is the NHS’s biggest spend on a single drug and, as the NHS develops the long term plan, we want more clinicians to switch to use the best value biologics which will free up hundreds of millions of pounds to reinvest back into patient care.”

NHS England recently announced plans to accelerate and widen the uptake of biosimilars in a bid to save up to £300 million a year by 2021 and, in 2017/18, the NHS managed to save over £200 million by doing so.

The National Rheumatoid Arthritis Society, National Ankylosing Spondylitis Society, Psoriasis Association and Crohn’s & Colitis UK have also voiced their support for NHS England’s plans to increase uptake of biosimilars.

“We welcome the increased availability of effective treatment options for patients and understand the importance of the wise and careful use of NHS resources,” they said in a joint statement.

“Our organisations have been working to provide patient information and support since 2014 and are familiar with the evidence to date which reinforces the fact that biosimilars are as safe and effective as the reference products. The introduction of biosimilars for adalimumab brings opportunities for both patients and the NHS.”

Amgen launched its Humira biosimilar Amgevita across Europe just yesterday, and another two versions are expected to hit the market before the end of the year.

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