Novartis’s Sandoz has secured European Commission’s approval for biosimilar Zessly, the company said Thursday.
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.
Richard Francis, CEO, Sandoz, said: “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.”
Zessly matched its reference medicine in terms of safety, efficacy and quality, according to the analytical, preclinical and clinical data, the company said. The clinical Phase III confirmatory study in rheumatoid arthritis met its primary endpoint, showing equivalent efficacy of Zessly to the reference medicine.
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.