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Novartis: Sandoz Proposed Biosimilar Adalimumab Matches Reference Biologic

Swiss drug giant Novartis (NVS) announced Thursday that Sandoz proposed biosimilar adalimumab matched reference biologic in terms of efficacy and safety in long-term study.

ADACCESS (NCT02016105) is a Phase III confirmatory randomized, double-blind, controlled, 51-week study to compare efficacy and safety between Sandoz biosimilar adalimumab and the reference medicine Humira.

Data from a long-term study of patients continuously treated with the proposed biosimilar or the reference medicine show that efficacy and safety profiles of the two medicines match throughout 51 weeks of treatment in patients with moderate-to-severe chronic plaque psoriasis.

Results were presented at the 26(th) Congress of the European Academy of Dermatology and Venereology (EADV) in Geneva, Switzerland.

Sandoz proposed biosimilar adalimumab is currently under review by the European Medicines Agency for the treatment of several immunological diseases.

Sandoz expects that approval of biosimilar adalimumab would further improve access to treatment for people living with immunological diseases.

The company said it plans to launch a total of five major oncology and immunology biosimilars between 2017 and 2020, including adalimumab.

by RTT Staff Writer

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