A pseudo-coloured image of high-resolution gradient-echo MRI scan of a fixed cerebral hemisphere from a person with multiple sclerosis. Credit: Govind Bhagavatheeshwaran, Daniel Reich, National Institute of Neurological Disorders and Stroke, National Institutes of Health.

Novartis unit Sandoz has signed an agreement with biopharmaceutical firm Polpharma Biologics for exclusive rights to commercialise a proposed biosimilar of Biogen’s multiple sclerosis drug natalizumab.

Financial details of the deal are yet to be disclosed by either company.

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Under the terms of the global agreement, Polpharma Biologics will develop, manufacture and supply the proposed biosimilar.

Meanwhile, Sandoz will be responsible for commercialising and distributing the product in all markets, following the receipt of necessary approvals.

Natalizumab is a disease-modifying therapy (DMT) approved as a treatment for relapsing-remitting multiple sclerosis (RRMS). Polpharma’s proposed biosimilar is currently in Phase III development for the condition.

According to previous studies, affordability is considered as the most common challenge to access MS therapy in 46% of the 90 surveyed countries. Gaining access to DMTs to treat the condition is a challenge for healthcare systems.

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Sandoz Biopharmaceuticals interim global head Pierre Bourdage said: “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.”

The proposed biosimilar version of natalizumab expands the company’s portfolio of generics, biosimilars, small molecules and new medicines.

Sandoz has a portfolio of eight marketed biosimilars, as well as more than ten other molecules in development.

In May, Sandoz and EirGenix agreed to commercialise a biosimilar of trastuzumab to treat certain breast and gastric cancers.

As part of the agreement, EirGenix will develop and manufacture the biosimilar. Sandoz holds the right to commercialise the product globally, except in China and Taiwan.