PB006, biosimilar of Tysabri, favored for approval in European Union

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended that PB006, a biosimilar version of Tysabri (natalizumab), be approved to treat adults with highly active relapsing-remitting multiple sclerosis (RRMS).

The recommendation comes about a year after the regulatory agency agreed to review the approval application submitted by Polpharma Biologics for its candidate as a biosimilar of Tysabri, Biogen’s approved multiple sclerosis (MS) treatment.

CHMP’s opinion now will be examined by the European Commission, which has final say over therapy approvals in the European Union. The commission is not obligated to abide by the committee’s findings, but it usually does.

If PB006 is approved, it would be the first biosimilar of Tysabri to enter the market. It will be sold by Sandoz, a division of Novartis, under a 2019 agreement with Polpharma Biologics.

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Active ingredient of PB006, like Tysabri, is natalizumab

“Today’s positive opinion from the CHMP is a clear step in the right direction to address the burden of the disease for those living with multiple sclerosis while also delivering savings for healthcare systems,” Pierre Bourdage, chief commercial officer at Sandoz, said in a company press release.

A similar application is under U.S. Food and Drug Administration review and covers the same indications as Tysabri’s in the country, which include clinically isolated syndrome, RRMS, and active secondary progressive MS, as well as Crohn’s disease, an inflammatory bowel condition.

Administered by intravenous infusion directly into the bloodstream, Tysabri is a disease-modifying MS therapy (DMT) that works by blocking the movement of immune cells into the brain and spinal cord, thereby reducing the inflammation that drives MS.

It has been available in Europe to treat adults with highly active RRMS since 2006.

Similar to generic versions of traditional medications, a biosimilar is a therapy that contains an identical active agent as an approved biological medication.

However, while generics can be chemically manufactured to be identical to the name-brand medicine, biological medicines and biosimilars are made using living cells, requiring special considerations during manufacturing and being subject to different regulations.

Biosimilars, like generics, bring competition into the treatment market

Biosimilars, like generics, also introduce more competition into the pharmaceutical marketplace, so they are usually cheaper than name-brand options and can help to put pressure on the market to lower costs.

“Access to affordable, high-quality treatments like disease-modifying therapies — which are a cornerstone in the treatment of multiple sclerosis — remains limited for many people living with this disease,” Bourdage said. “At Sandoz, we are committed to accelerating access to potentially life-changing treatments to patients in need around the world.”

CHMP’s positive recommendation was based on a package of data showing that PB006 is pharmacologically comparable to name-brand Tysabri.

This includes results from the Phase 3 ANTELOPE clinical trial (NCT04115488), which tested the two infusion therapies against each other in 264 people with RRMS. Results, published in a scientific journal earlier this year, demonstrated that the biosimilar had a similar efficacy and safety profile as the name-brand medicine.