Research & Development
US FDA accepts Sandoz's Biologics License Application for proposed biosimilar adalimumab
16 January 2018 -

The US Food and Drug Administration (FDA) has accepted from Novartis' Sandoz division the Biologics License Application submitted under the 351 (k) pathway, for proposed biosimilar, adalimumab, to the reference medicine, Humira, it is reported today.

The product is indicated for the treatment of a number of inflammatory diseases including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.

The comprehensive data package submitted to the US FDA that includes analytical, preclinical and clinical data, is intended to demonstrate that Sandoz's adalimumab matches the reference biologic in terms of safety, efficacy and quality. Clinical studies submitted to the FDA include a pharmacokinetic study in healthy volunteers and a Phase III confirmatory safety and efficacy study in patients with moderate to severe chronic plaque-type psoriasis.