Research & Development
Sandoz submits proposed biosimilar adalimumab BLA with the US FDA for treating immunological diseases
17 January 2018 -

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

The company said adalimumab is an anti-TNF medicine used to treat immunological diseases and inflammatory diseases including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis1. Rheumatoid arthritis alone affects 1.5m Americans with 200,000 new cases diagnosed each year.

According to the company, the comprehensive data package submitted to the US FDA, which comprises analytical, preclinical and clinical data, is expected to demonstrate that its proposed biosimilar adalimumab matches the reference biologic in terms of safety, efficacy and quality.

In conjunction, the clinical studies submitted to the US FDA include the company's pharmacokinetic study in healthy volunteers as well as a Phase III confirmatory safety and efficacy study in patients with moderate to severe chronic plaque-type psoriasis (ADACCESS).

Sandoz is committed to increasing patient access to high-quality biosimilars and is a division of Novartis, a healthcare company.