Natalizumab Biosimilar in Development Reaches Phase 3 Trial for Multiple SclerosisTreatment

Polpharma Biologics (Warsaw, Poland) and Sandoz (Princeton, NJ) have reached a global commercialization agreement for a proposed natalizumab (Biogen, Cambridge, MA) biosimilar to treat relapsing-remitting multiple sclerosis (RRMS). The investigational biosimilar is in clinical development. 

Under the agreement, Polpharma Biologics will be responsible for developing, manufacturing, and supplying the proposed biosimilar; Sandoz will commercialize and distribute the medicine in all markets. The reference medicine, natalizumab, is a disease-modifying therapy (DMT) approved for use more than 10 years ago. Natalizumab is a valuable therapeutic option for treating RRMS, which affects about 85% of MS patients. 

In addition to the personal burden that MS imposes on patients and families, affordability is a significant challenge for MS medicines globally. A recent report from the Multiple Sclerosis International Foundation highlighted affordability as the most common obstacle that affects access to MS therapy in 46% of the 90 countries comprising their membership. .

“. . . access to advanced medicines is important for all people diagnosed with a chronic disease, but the challenges are very pronounced for MS,” said Pierre Bourdage, ad interim global head of biopharmaceuticals, Sandoz. “By nature, biosimilars create competition and cost savings, which are proven to make room in healthcare systems to treat more patients. With this agreement, we hope to build on our MS experience with small molecules and complex generics, and ultimately provide patients with expanded access to a DMT that healthcare systems may otherwise not be able to provide.”