FDA Accepts Sandoz Regulatory Submission for Adalimumab
18 January 2018 - - The US Food and Drug Administration has accepted the biologics license application from Holzkirchen, Germany-based biosimilar medicines specialist Sandoz, a Novartis division, submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira, the company said.
Adalimumab 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 FDA, which comprises analytical, preclinical and clinical data, is expected to demonstrate that Sandoz proposed biosimilar 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 (ADACCESS).
Sandoz has five biosimilars marketed in various countries worldwide, as well as a leading global pipeline.
Sandoz focuses on generic pharmaceuticals and biosimilars. A division of the Novartis Group, its purpose is to discover new ways to improve and extend people's lives and to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine.
The company's portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of 10.1 bn. In 2016, its products reached well over 500 million patients.