Amgen, Novartis first to launch Humira biosimilars in Europe

Amgen announced Tuesday the launch of Amgevita, a biosimilar version of AbbVie's Humira (adalimumab), in markets across Europe following loss of marketing exclusivity on the reference product. Amgen noted that Amgevita will launch in the 28 countries that are members of the EU, as well as in Norway, Iceland and Liechtenstein.

Meanwhile, Novartis said its Sandoz unit launched its Humira biosimilar Hyrimoz in the UK on Tuesday, with other markets in the EU set to follow. Neither Amgen or Novartis have disclosed prices for their products, although a spokesperson for the former noted that there would be cost savings for patients, hospitals and health systems. Humira generated global revenue of $18 billion last year, with about $4 billion coming from sales in Europe.

In 2017, Amgevita became the first Humira biosimilar approved in Europe, with the product authorised in all available indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn's disease and ulcerative colitis. Amgen's product will be available in a prefilled syringe and pre-filled pen, dubbed SureClick autoinjector.

Along with Amgevita and Hyrimoz, regulators in Europe have approved a further two biosimilar versions of Humira, including Samsung Bioepis' Imraldi, and Mylan and Fujifilm Kyowa Kirin Biologics' Hulio, which are set to launch in the region. However, a third version from Boehringer Ingelheim, called Cyltezo, will not be launched in Europe due to ongoing patent litigation with AbbVie in the US.

Meanwhile, AbbVie has settled US patent litigation surrounding biosimilar versions of Humira with Amgen, Biogen and partner Samsung Bioepis, Mylan and most recently with Sandoz, allowing the products to be launched in 2023.

For related analysis, see ViewPoints: Humira on the cusp as biosimilar D-Day nears in Europe.

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