SWITZERLAND – Sandoz’s biologics license application (BLA) has been accepted by the US Food and Drug Administration (FDA) for a proposed ‘first-of-a-kind’ biosimilar natalizumab, developed by Polpharma Biologics, for the treatment of multiple sclerosis (MS) and Crohn’s disease.

The drug is a biosimilar to Biogen’s Tysabri, commonly known as natalizumab. According to Sandoz, the biosimilar in patients with relapsing-remitting MS was similar to Tysabri in efficacy, safety and immunogenicity.

The BLA for the biosimilar has been accepted by both US and EU authorities, Sandoz said.

A marketing authorization application (MAA) for natalizumab was accepted on 15 July 2022 by the European Medicines Agencies (EMA), as a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS).

Both applications were supported by a comprehensive analytical, preclinical and clinical data package, including positive results from the phase 1 and phase 2 Antelope studies in Relapsing-remitting multiple sclerosis (RRMS) patients.

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

MS is a debilitating, neurodegenerative and inflammatory disease where the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body.

According to Sandoz, the biosimilar in patients with relapsing-remitting MS was similar to Tysabri in efficacy, safety and immunogenicity.

MS affects 700,000 people in Europe and approximately 2.5 million people worldwide.

Relapsing forms of MS are characterized by clearly defined but unpredictable attacks of worsening neurologic function, followed by partial or complete recovery periods.

Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared with 10-15% with progressive forms of the disease.

Florian Bieber, global head of biopharmaceuticals development at Sandoz, said: “Thanks to advances in medicine over the last 20 years, we now have DMTs, which have become a cornerstone in the treatment of MS. However, access to affordable, high-quality treatment options is still a challenge.

“This is the first and only submission for a biosimilar natalizumab medicine in both the US and Europe. If approved, this biosimilar has the potential to increase access while also delivering savings for healthcare systems.”

Sandoz and Polpharma Biologics signed a global commercialization agreement for the proposed biosimilar natalizumab in 2019.

As part of that agreement, Polpharma Biologics will develop, manufacture and supply the biosimilar, while Sandoz will commercialize and distribute the biosimilar in all markets through an exclusive global license.

Tysabri was first approved in 2004 for relapsing forms of MS and then approved in 2008 for Crohn’s disease.

The drug is one of the earliest in Biogen’s line of MS therapies. Biogen is also facing declining sales of its backbone MS drug Tecfidera due to generic competition, and was denied a rehearsal in March after it lost its appeal on a Tecfidera patent late last year.

In 2021, Biogen made just over US$2 billion in Tysabri sales and US$1.95 billion in Tecfidera sales, compared to US$3.8 billion the year before.

Sandoz said it would pursue all indications in which Tysabri is approved for its biosimilar version, which is being developed by Polpharma Biologics.

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