Sandoz, a Novartis division and a global leader in biosimilars, announced that it has entered into a global commercialization agreement for a proposed natalizumab biosimilar. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS).
RRMS affects ~85% of MS patients and can create a substantial social and economic burden on patients, their families and healthcare systems.
Under the agreement, Polpharma Biologics will maintain responsibilities for development, manufacturing and supply of proposed biosimilar natalizumab. Sandoz will commercialize and distribute the medicine in all markets upon approval, through an exclusive global license. Other specific terms of the agreement are confidential. Polpharma Biologics is a European biopharmaceutical company with a fully integrated R&D and manufacturing footprint.
Reference medicine natalizumab is a disease-modifying therapy (DMT) that was approved for use over 10 years ago, offering patients a valuable therapeutic option for treating RRMS.
Natalizumab was originally approved for treatment of multiple sclerosis in 2004, through the FDA’s accelerated Fast Track program, due to the drug’s efficacy in one-year clinical trials. In February 2005, four months after its approval, natalizumab was withdrawn voluntarily by the manufacturer after two cases of progressive multifocal leukoencephalopathy.
In April, 2006 the Committee for Medicinal Products for Human Use recommended authorizing natalizumab to treat relapsing-remitting MS, and several weeks later the European Medicines Agency approved natalizumab in the European Union for highly-active relapsing remitting MS.
Health Canada added natalizumab to Schedule F of the Food and Drug Regulations on April 3, 2008 as a prescription drug requiring oversight from a physician.
In 2007 the EMA rejected the application to market natalizumab for Crohn’s disease due to concerns over its risk/benefit ratio. In January 2008, the FDA approved it for the induction of remission and maintenance of remission for moderate to severe Crohn’s disease.