Natalizumab, Tysabri Biosimilar, Up for Approval in Europe

The European Medicines Agency (EMA) has agreed to review a request to approve Polpharma Biologics‘ biosimilar natalizumab for the treatment of multiple sclerosis (MS).

This marks the first time the regulatory agency accepted a marketing authorization application for a biosimilar of Tysabri, an approved MS treatment.

“The acceptance of the filing of proposed biosimilar natalizumab by the European regulatory authorities means we are a critical step closer to getting this important medicine to the patients who need it the most,” Michael Soldan, Polpharma’s CEO, said in a company press release.

Tysabri is an antibody-based therapy that works by binding to an immune cell receptor called alpha-4-beta-1-integrin, which prevents immune cells from crossing from the blood into the central nervous system (the brain and spinal cord).

Administered via infusions into the bloodstream, the therapy reduces the inflammatory nervous system damage that drives MS, leading to reduced relapse rates and slower disease progression. The name-brand therapy is marketed by Biogen.

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Natalizumab as a biosimilar for MS

In the European Union, Tysabri is approved to treat adults with relapsing-remitting MS (RRMS) who have highly active disease. It is approved for adults with relapsing forms of MS in the U.S.

A biosimilar is a therapy designed to have an identical active ingredient as a name-brand biologic medicine. Conceptually, biosimilars are analogous to generic medications. The main difference is that, where traditional generics can be chemically manufactured, antibody-based therapies and other biologics require the use of living cells in their production, so regulatory structures are different.

Since biosimilars introduce more competition into the pharmaceutical marketplace, they can help to reduce medication costs. According to Polpharma, the high cost of treatment leads to a substantial economic burden for people with MS, and patients with moderate-to-severe disease commonly incur yearly costs between €37,000 to €57,000 (about $37,600 to $58,000).

Polpharma’s EMA application is supported in part by data from a Phase 3 clinical trial called Antelope (NCT04115488). The trial enrolled 264 people with RRMS, who were randomly assigned to monthly treatment with either Tysabri or Polpharma’s biosimilar for about one year.

Antelope trial results, presented at this year’s American Academy of Neurology (AAN) annual meeting, broadly showed that the biosimilar was comparable to Tysabri in terms of its efficacy at reducing inflammatory activity on MRI scans. The safety and tolerability profile of the biosimilar also was comparable to that of the name-brand medication.

“We are deeply proud of the dedication of our scientific teams to take biosimilar natalizumab from cell line and technical development, through clinical trials to registration — today’s milestone is testament to their achievements,” Soldan said.

The biosimilar was developed by Polpharma, and the company retains responsibility for making the therapy. If approved, the biosimilar would be commercialized and distributed by Sandoz, a division of Novartis, under the terms of a 2019 agreement between the two companies.