Sandoz announce global deal to comercialise natalizumab

graphic of handshake with couple signing a contract in background to depict Cytel acquires MTEK Sciences

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

Under the agreement, Polpharma Biologics, a European biopharmaceutical company with a fully integrated R&D and manufacturing footprint, will maintain responsibilities for development, manufacturing and supply of proposed biosimilar natalizumab. Sandoz will commercialise and distribute the medicine in all markets upon approval, through an exclusive global license. Other specific terms of the agreement are confidential.

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.

In addition to the personal burden of MS for patients and families, affordability is a significant challenge for MS medicines globally. A recent report highlighted affordability as the most common challenge affecting access to MS therapy in 46% of the 90 countries included. Elsewhere it has been highlighted that providing access to DMTs for MS represents a considerable challenge for healthcare systems.

Pierre Bourdage, ad interim Global Head of Biopharmaceuticals, Sandoz, said: “Patient access to advanced medicines is important for all people diagnosed with a chronic disease, but the challenges are very pronounced for MS patients.

“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.”