The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) from Sandoz, a Novartis (VTX: NOVN) division, for proposed biosimilar adalimumab to the reference medicine Humira, the company disclosed on Tuesday.

Adalimumab is indicated as a treatment for numerous inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis.

In the US, rheumatoid arthritis affects around 1.5 million people. Every year there are approximately 200,00 new cases diagnosed, with women disproportionately affected by the disease.

The company's submission to the FDA included analytical, preclinical and clinical data. It is expected to demonstrate Sandoz's proposed biosimilar matches the reference biologic in terms of safety, efficacy and quality.

Included in the submission is a pharmacokinetic study involving healthy volunteers and a Phase III confirmatory safety and efficacy study in patients with moderate-to-severe chronic plaque-type psoriasis.