Sandoz, a Novartis division, announced that the European Commission (EC) has approved Zessly (infliximab) for use in Europe.
Zessly is approved for use in all indications of the reference medicine, Remicade, including rheumatoid arthritis, adult Crohn’s disease, pediatric Crohn’s disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
“The European Commission approval for Zessly is a key milestone in bringing this important medicine to appropriate patients,” said Richard Francis, CEO, Sandoz. “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]
Zessly is the sixth approved biosimilar medicine for Sandoz, with several more 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.
Remicade® is marketed by MSD in Europe and is a registered trademark of Janssen Biotech, Inc.
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Reference:
[1] Cohen, SB. A Randomized, Double-Blind Study Comparing PF-06438179/GP1111, a Potential Infliximab Biosimilar, and Infliximab, Both in Combination with MTX, As Treatment for Patients with Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Therapy. Available at: https://acrabstracts.org/abstract/a-randomized-double-blind-study-comparing-pf-06438179gp1111-a-potential-infliximab-biosimilar-and-infliximab-both-in-combination-with-mtx-as-treatment-for-patients-with-moderate-to-severe-active/. Accessed on 20 March 2018.
(Source: Novartis International AG)
Filed Under: Drug Discovery
