Novartis, Mylan, Amgen, Samsung Bioepis Launch Biosimilars to AbbVie’s Humira in EU
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Novartis’ Sandoz, Mylan, Amgen, and Samsung Bioepis have launched in the European Union (EU) biosimilars to AbbVie’s Humira (adalimumab), an anti-inflammatory drug and AbbVie’s top-selling drug with global 2017 sales of $18.43 billion. The four companies previously formed separate agreements with AbbVie to launch their biosimilars of Humira in the EU and US.

In October 2018, AbbVie and Sandoz, Novartis’ generics arm, signed a resolution of all intellectual property-related litigation concerning Sandoz’s proposed biosimilar to AbbVie’s Humira. AbbVie previously formed similar agreements between 2017 and 2018 with Mylan, Amgen, and Samsung Bioepis, a biosimilars joint venture of Biogen and Samsung BioLogics, an Incheon, South Korea-based contract biologics manufacturer. Under the deals, all four companies launched the biosimilars in the EU on October 16, 2018 and will launch their biosimilars in the US in 2023. Under the deals, Amgen will launch its Humira biosimilar in the US in January 2023, Samsung Bioepis in June 2023, Mylan in July 2023, and Sandoz in September 2023.

Novartis’ Sandoz launched its Humira biosimilar under the name Hyrimoz (adalimumab). Mylan launched its biosimilar under the name Hulio (adalimumab). Amgen named its biosimilar Amgevita (adalimumab). Biogen and Samsung Bioepis launched their Humira biosimilar under the name Imraldi (adalimumab).

Humira had brand sales of approximately $4.3 billion in Europe for the 12 months ending July 31, 2018, according to IQVIA, and as reported by Mylan.

Source: Amgen, Mylan, Samsung Bioepis

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