The U.S. Food and Drug Administration (FDA) has accepted the Sandoz Biologics License Application (BLA), submitted under the 351 (k) pathway, for the proposed biosimilar adalimumab to the reference medicine, Humira*.
“When patients are dealing with a chronic disease, it is imperative they have access to important medication that will help best manage their health,” said Mark Levick, global head of development, biopharmaceuticals, Sandoz. “The FDA’s acceptance of the regulatory submission for our biosimilar adalimumab brings us one step closer to offering a portfolio of options to the millions of patients in the U.S. who suffer from an inflammatory disease.”
Adalimumab is indicated for the treatment of a number of inflammatory diseases including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis1. Rheumatoid arthritis alone affects approximately 1.5 million Americans with 200,000 new cases diagnosed each year5,6. Women are disproportionately (3:1) affected by the disease5.
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)2-4.
Sandoz, a Novartis division, has five biosimilars marketed in various countries worldwide.
*Humira® is a registered trademark of AbbVie Biotechnology Ltd.
1 Humira® Highlights of Prescribing Information, 2002. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf. Last accessed December 2017.
2 Blauvelt A et al. A randomized, double-blind, multicenter study to compare the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (GP2017) with originator adalimumab Poster #5224 presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting, 3-7 March 2017.
3 Blauvelt A et.al. Long-Term Efficacy, Safety and Immunogenicity Results from a Randomized, Double-Blind, Phase III Confirmatory Efficacy and Safety Study Comparing GP2017, a Proposed Biosimilar, with Reference Adalimumab [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). American College of Rheumatology (ACR) Annual Meeting, US, 3-9 November 2017.
4 Jauch-Lembach J, et.al. Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). American College of Rheumatology (ACR) Annual Meeting, US, 3-9 November 2017.
5 Sholtzhauer, T.L. (2014). Living with Rheumatoid Arthritis. Available at: https://books.google.co.uk/books?id=ouURBAAAQBAJ&lpg=PR17&dq=200. Last accessed December 2017.
6 Arthritis Foundation. What is Rheumatoid Arthritis? Available at: https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Last accessed December 2017
(Source: Novartis Pharmaceuticals Corp.)
Filed Under: Drug Discovery