Novartis’ Sandoz Buys European Rights to Biosimilar Remicade

Novartis’ Sandoz unit has acquired from Pfizer rights to develop and commercialize a biosimilar to Remicade® (infliximab) in the 28-nation European Economic Area (EEA) for an undisclosed price.

Like its reference product, infliximab (PF-06438179) is a tumor necrosis factor alpha (TNF-alpha) inhibitor designed to treat a range of autoimmune diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and plaque psoriasis.

Sandoz said it plans to complete clinical studies for biosimilar infliximab, then pursue regulatory approval with the European Medicines Agency and registration with the European Commission.

The clinical program for biosimilar infliximab includes the global Phase III REFLECTIONS (B537-02) trial, intended to compare the safety and efficacy of PF-06438179 with the combination of infliximab and methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate.

Pfizer retains commercialization and manufacturing rights outside of the EEA—including in the U.S., where the company is pursuing development of biosimilar infliximab with Celltrion.

Remicade is marketed by Janssen Biotech, whose parent Johnson & Johnson on January 26 reported sales for the drug slipped 4.5% last year, compared with 2014, to $6.561 billion.