Novartis ’ subsidiary Sandoz has secured approval from the European Commission (EC) for its biosimilar product Zessly (infliximab) to treat gastroenterological, rheumatological and dermatological diseases.
Zessly is designed to inhibit the activity of tumour necrosis factor (TNF)-alpha in some autoimmune diseases, for which excess TNF-alpha activity may be harmful or lead to their onset.
This inhibition is intended to help in addressing an underlying cause of inflammation.
The approval covers use of Zessly for the treatment of all indications of the reference medicine, including Crohn’s disease, rheumatoid arthritis, ulcerative colitis, plaque psoriasis, ankylosing spondylitis and psoriatic arthritis.
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 regulatory agency’s decision is based on a comprehensive development programme that included analytical, preclinical and clinical data.
These findings are reported to have validated that the safety, efficacy and quality of Zessly are similar to that of the reference medicine.
The EC also reviewed results from the Phase III confirmatory study which met its primary endpoint of equivalent efficacy in patients suffering from rheumatoid arthritis.
Zessly is Sandoz’s sixth biosimilar medicine to gain approval, and expands its current portfolio of Omnitrope, Binocrit, Zarzio, Erelzi and Rixathon.
The company is planning for commercial launch of multiple oncology and immunology products by 2020.