Four adalimumabs compete in EU
Four separate biosimilar versions of AbbVie’s Humira (adalimumab) are competing for market share in the European Union (EU), after Amgen, Mylan, Samsung Bioepis and Sandoz all launched into European markets immediately after a key supplementary protection certificate (SPC) protecting the autoimmune treatment expired. Amgen, Mylan and Samsung Bioepis said their respective Amgevita, Hulio and Imraldi biosimilars had launched in markets across Europe, including in Italy for Amgen. A Sandoz spokesperson told Generics bulletin the company – which has received approval under the Hyrimoz, Halimatoz and Hefiya labels – had “launched and supplied” its adalimumab in Germany and the UK, while it had placed tender bids in the Netherlands and Ukraine.
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Alvotech has announced the filing of its AVT02 higher-strength adalimumab version of Humira 100mg/ml with both the FDA and the EMA, as well as disclosing expected decision dates. Teva will market the biosimilar in the US and Stada in Europe.
Samsung Bioepis is lining up two biosimilar bevacizumab products in the EU, after the EMA’s CHMP recommended the company’s Onbevzi product months after approval for Aybintio.
Mylan’s Hulio has become the sixth biosimilar version of Humira to be approved by the US FDA. However, all of these adalimumab biosimilars face a wait until 2023 before they can enter the market.