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First Humira biosimilars reach EU market

World’s biggest selling medicine to lose billions in sales.
The roll-out of biosimilars of AbbVie’s Humira – the top-selling drug in the world – has got underway in Europe as the brand’s market exclusivity comes to an end.
Copycat versions of the TNF inhibitor  from Amgen, Samsung Bioepis/Biogen, Mylan/Fujifilm Kyowa Kirin, and Novartis’ Sandoz unit are starting to become available in their first EU markets now that AbbVie’s patent protection for Humira (adalimumab) has come to an end in Europe.
Humira made $18bn in revenues last year – mostly in the US but with around $6bn from the rest of the world – and is widely used to treat a range of inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn’s disease. Europe is thought to be the second-largest regional market with sales above $4bn, and AbbVie is expected to see its revenues there rapidly erode from early 2019. It is still claiming patent protection in the US until 2023.
Among those launched on the day patent protection for AbbVie’s ‘originator’ product ended is Sandoz’ Hyrimoz. This is now available in the UK with other EU markets to follow. There’s no official word on pricing yet from any company, but Sandoz predicts that use of its drug could cut the NHS’ annual £500m ($658m) bill for Humira in half.
NHS England’s Commercial Medicines Unit (CMU) is co-ordinating a national procurement process for adalimumab with the aim of saving £200-300m by 2021 through the increased use of ‘best value’ adalimumab products.
Sandoz also suggests that the availability of biosimilars means that more patients in the UK will be able to get access to adalimumab therapy, and it has stockpiled supplies of Hymiroz to ensure that there would be uninterrupted supply in the event of a no-deal Brexit.
Also already launched is Samsung Bioepis and Biogen’s Imraldi is also close to launch in their first markets, while Amgen’s Amgevita, which was the first Humira biosimilar to get EMA approval is waiting in the wings but not yet launched.
For Amgen it is its second biosimilar product approval in Europe after Mvasi (bevacizumab), a version of Roche’s cancer drug Avastin. Samsung Bioepis already has two other biosimilar TNF inhibitors available in Europe – Benepali (etanercept) and Flixabi (infliximab) – giving it an opportunity to quickly leverage its established sales channels in rolling out Imraldi.
There is no word yet on the roll-out plans for Mylan/Fujifilm Kyowa Kirin’s Hulio, the latest biosimilar to be approved last month. At the time the two partners said they would launch “on or after 16 October when Humira’s EU patent expires.
Meanwhile, a fifth biosimilar called Cyltezo from Boehringer Ingelheim has been approved for sale but its launch has been held up by patent litigation with AbbVie, according to a Financial Times report.
Lawsuits involving other biosimilar adalimumab developers – namely Amgen, Samsung Bioepis and Sandoz – were resolved on the understanding that they did not launch in the US until the 2023 patent expiry.