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.
“We intend to complete the development and registration of PF-06438179 and make it available to patients across Europe as part of our robust portfolio of immunology treatments,” Richard Francis, Global Head of Sandoz, said in a statement.
Pfizer agreed to divest itself of the biosimilar infliximab program in Europe in return for European Commission approval of the pharma giant’s acquisition of Hospira last year. The deal—the third-largest M&A transaction of 2015—was completed September 3 for approximately $16 billion.
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.
On Tuesday, the FDA’s Arthritis Advisory Committee voted 21-3 to recommend approval of the Remicade near-copy, which until now has been called CPT-P13 but will be marketed under the name Remsima.
Advisory committee recommendations are typically, but not always, followed by the FDA. If the agency approves Remsima, it would be the second biosimilar authorized for use in the U.S. The first is Zarxio™ (filgrastim-sndz), a variation of Amgen’s Neupogen (filgrastim), launched in September by Sandoz.
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.