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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Sandoz is looking to enter the European market for high-concentration adalimumab after announcing EMA acceptance of its filing for a 100mg/ml version of its Hyrimoz biosimilar. Celltrion and Stada/Alvotech already have higher-strength rivals to Humira available in Europe.
Oral delivery of biosimilars could bring significant benefits for patients as well as offering a key differentiating factor for competing developers, especially in the US adalimumab arena, Rani Therapeutics CEO Talat Imran tells Generics Bulletin.
The key advantages of the European centralized procedure, its usage by generics and biosimilars developers and the EU Pharmaceutical strategy and legislation were discussed at length in a recent webinar hosted by Medicines for Europe.