Novartis Gains EC Approval for Infliximab Biosimilar

On May 24, 2018, Sandoz, a Novartis division, announced that the European Commission (EC) has approved Zessly (infliximab) for use in Europe. Zessly is a biosimilar to Johnson & Johnson’s blockbuster autoimmune biologic, Remicade (infliximab), which had 2017 sales of approximately $6.3 billion.

Zessly is approved for use in all indications of the reference biologic, 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, in a company press release. "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 drug is the sixth approved biosimilar medicine for Sandoz, with several more major oncology and immunology launches expected globally by 2020.

Sandoz acquired infliximab (PF-06438179) development, commercialization, and manufacturing rights from Pfizer in February 2016 for the 28 European Union countries plus Norway, Iceland, and Liechtenstein that form the European Economic Area (EEA). Under the terms of the divestment, Pfizer retains commercialization and manufacturing rights to infliximab (PF-06438179) in countries outside the EEA.

Source: Novartis