Sandoz edges closer to European market with Humira and Remicade biosimilars
Sandoz, a division of Swiss pharma giant Novartis (NOVN: VX), has had its proposed adalimumab and infliximab biosimilars accepted for regulatory review by the European Medicines Agency (EMA).
The company is seeking approval for these biosimilars for use in all indications of their respective reference medicines, with the adalimumab product a copy of Humira from US drugmaker AbbVie (NYSE: ABBV), and infliximab referencing Remicade from Janssen, the pharma unit of healthcare giant Johnson & Johnson (NYSE: JNJ). Both are used to treat immunological diseases.
Comprehensive data packages demonstrate each biosimilar matches its respective reference medicine in terms of quality, efficacy and safety, Sandoz says.
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