Sandoz, a Novartis division, has announced that its multiple sclerosis (MS) biosimilar has been recommended by the European Medicines Agency’s (EMA) human medicines committee as a single disease-modifying therapy in adults with highly active relapsing-remitting forms of the disease.

The “first-of-a-kind” biosimilar natalizumab, developed by Polpharma Biologics, is a version of Tysabri (natalizumab). Biosimilars, according to the EMA, are biological products that are highly similar to a medicine already approved in the EU.

The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they could potentially lower healthcare costs.

Pierre Bourdage, chief commercial officer, Sandoz, said: “Access to affordable, high-quality treatments like disease-modifying therapies – which are a cornerstone in the treatment of MS – remains limited for many people living with this disease.”

Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves, disrupting communication between the brain and the rest of the body.

Relapsing-remitting MS accounts for approximately 85% of MS cases and is characterised by episodes of new or worsening signs or symptoms followed by periods of recovery.

The Committee for Medicinal Products for Human Use’s (CHMP) decision was supported by evidence from an "extensive analytical characterisation” confirming similarity of the biosimilar with the reference biologic, Sandoz said, in addition to phase 1 and confirmatory phase 3 studies in relapsing-remitting MS patients.

Each study met its primary endpoints, demonstrating that the biosimilar matches the reference medicine in terms of efficacy, safety and immunogenicity.

Bourdage said: “[The] positive opinion from the CHMP is a clear step in the right direction to address the burden of the disease for those living with MS while also delivering savings for healthcare systems.”

Sandoz and Polpharma Biologics signed a global commercialisation agreement for biosimilar natalizumab in 2019. As part of the deal, Polpharma Biologics will develop, manufacture and supply the biosimilar, while Sandoz will commercialise and distribute the biosimilar in all markets through an exclusive global licence.

Polpharma Biologics Group’s chief executive officer, Michael Soldan, said: “We are now looking forward to supporting our partner Sandoz to bring biosimilar natalizumab to patients, while continuing to advance the development of our biosimilars pipeline which will broaden our ability to offer affordable access to life-changing medicines.”

Source: pmlive.com