Sandoz said on Monday that it has successfully submitted its Biologics License Application (BLA) with the US Food and Drug Administration (FDA) under the 351 (k) pathway for proposed biosimilar adalimumab to the reference medicine, Humira.

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

The company stated the comprehensive data package submitted to the US FDA comprises of analytical, preclinical and clinical data from the proposed biosimilar adalimumab.

In conjunction, the clinical studies submitted to the US 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 (ADACCESS). The study is expected to demonstrate that the company's proposed biosimilar adalimumab matches the reference biologic in terms of safety, efficacy and quality.

Sandoz is the first global healthcare company to establish a leading position in both innovative and off-patent medicines and is part of Novartis.