Natalizumab: Multiple Sclerosis | Uses | Side Effects

Sandoz to Commercialize Proposed Multiple Sclerosis Biosimilar Natalizumab

Sandoz to commercialize proposed multiple sclerosis biosimilar natalizumab:

Sandoz, a Novartis division and a global leader in biosimilars, has announced that it has entered into a global commercialization agreement for a proposed natalizumab biosimilar. The medicine is currently in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS).

RRMS affects 85% of MS patients, creating 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 the 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 remain confidential.

Polpharma Biologics is a European biopharmaceutical company with a fully integrated R&D and manufacturing footprint. Natalizumab, a disease-modifying therapy (DMT), was originally approved for use over 10 years ago and remains a valuable option for treating RRMS.

Natalizumab was first approved for the treatment of multiple sclerosis in 2004 under the FDA’s Fast Track program due to its efficacy in clinical trials. However, it was withdrawn in 2005 following concerns over cases of progressive multifocal leukoencephalopathy. By 2006, the Committee for Medicinal Products for Human Use and the European Medicines Agency approved natalizumab in the EU for highly active relapsing-remitting MS. Health Canada followed suit in 2008, adding natalizumab to its prescription drug list.

While natalizumab was rejected for Crohn’s disease by the EMA in 2007 due to risk concerns, it was later approved by the FDA in 2008 for the induction and maintenance of remission for moderate to severe Crohn’s disease.