Regulatory Affairs

EC approves Sandoz' Zessly to treat gastroenterological, rheumatological and dermatological diseases

Published 25 May 2018

Sandoz has secured approval from the European Commission for Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.

Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Sandoz CEO Richard Francis said: "The European Commission approval for Zessly is a key milestone in bringing this important medicine to appropriate patients.

"Biosimilars, such as Zessly, help to address a significant unmet need for earlier patient access to biologic medicines and are at the heart of our Sandoz commitment to improving and extending lives."

The EC approval was based on review of a comprehensive development program, including analytical, preclinical and clinical data, which confirmed Zessly matched its reference medicine in terms of safety, efficacy and quality.

The clinical Phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02) met its primary endpoint, demonstrating equivalent efficacy of Zessly to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.[1]

As a Novartis division, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. Zessly is the sixth approved biosimilar medicine for Sandoz, with several more major oncology and immunology launches expected globally by 2020.

Zessly blocks the action of tumor necrosis factor (TNF)-alpha in patients with certain autoimmune diseases in which excess TNF-alpha activity may be harmful or cause onset of disease. By blocking the action of TNF-alpha, infliximab inhibits an underlying cause of inflammation.

Source: Company Press Release