Posted by Michael Wonder on 16 Jan 2018
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
16 January 2018 - The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab matches the reference biologic medicine in terms of safety, efficacy and quality.
Sandoz announced today that the US FDA has accepted its biologics license application, submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira.
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).
