New data reinforces clinical basis for switching to Sandoz biosimilar medicines

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• Sandoz strengthens position as global leader in biosimilars with new immunology data from four clinical studies for proposed biosimilars adalimumab and rituximab

Efficacy and safety of biosimilar adalimumab and safety of biosimilar rituximab match reference medicines in multiple-switching and retreatment study respectively 

Sandoz biosimilar adalimumab is under EMA review, while EC-approved Sandoz biosimilar rituximab is under review by the FDA

Holzkirchen, November 14, 2017- Sandoz, a Novartis division and the global leader in biosimilars, today announces data from four clinical studies comparing its proposed biosimilar adalimumab and biosimilar rituximab with their reference medicines, Humira^®* and MabThera^®/Rituxan^®** respectively[1]-[4].

Studies included two innovative trials involving switching and two pharmacokinetic (PK) and pharmacodynamic (PD) studies. The results were presented at the American College of Rheumatology (ACR) Annual Meeting in San Diego, US.

Innovative studies involving switching:

• A Phase III confirmatory efficacy and safety study met its primary endpoint in the proportion of patients who achieved a 75% improvement at Week 16, as measured by the Psoriasis Area and Severity Index (PASI)[5]. Further the impact of switching between Sandoz biosimilar adalimumab and its reference medicine in patients with moderate-to-severe chronic plaque psoriasis was assessed. This innovative study design included continuous and 'switch' treatment arms. The study confirmed no clinically meaningful differences in efficacy, safety and immunogenicity between patients who continuously received biosimilar adalimumab, those who continuously received the reference medicine and those who switched between biosimilar adalimumab and reference medicine on multiple occasions[1].