Biosimilar to Tysabri for Relapsing-Remitting MS Is On Its Way

A biosimilar to Tysabri (natalizumab) may be available in the U.S. in the near future.

Sandoz recently announced that the FDA has accepted its biologics license application for a Tysabri biosimilar. The European Medicines Agency also accepted Sandoz’s marketing authorization application.

The applications include all indications covered by Tysabri for relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome, relapsing-remitting MS (RRMS), active secondary progressive disease in adults, and Crohn´s Disease.

“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,” said Florian Bieber, global head of Biopharmaceuticals Development at Sandoz, in a news release.

It typically takes 12 months after submission to receive a decision from the FDA, Leslie Pott, vice president of communications for Sandoz, told Managed Healthcare Executive®. “It is too early to comment on country launch sequence; however, we aim to launch as soon as possible. As with every biosimilar, we aim to make biologics more available and affordable to patients worldwide,” Pott said.

The new medication could make a significant impact in the MS treatment market, and cut into Tysabri’s sales, which reached nearly $2.4 billion in 2021, according to IQVIA.

The MS market is expected to grow by 3% in sales (CAGR 2021 - 2030), according to Sandoz. Around 2.8 million people globally have MS, and 85% are affected by relapsing-remitting MS, “which creates a substantial social and economic burden on patients, their families and healthcare systems,” according to the Multiple Sclerosis International Federation report, Global Economic Impact of Multiple Sclerosis.

“Thanks to advances in medicine over the last 20 years, we now have DMTs (disease-modifying therapies), which have become a cornerstone in the treatment of MS. However, access to affordable, high-quality treatment options is still a challenge,” Bieber noted in the press release

Sandoz’s Phase 1 and Phase 3 Antelope studies in RRMS patients met their primary endpoints, showing that the biosimilar matches the reference medicine in terms of efficacy, safety and immunogenicity.

“Sandoz is committed to all aspects of the safe use of, and patient experience with, its proposed biosimilar natalizumab. This includes a JCV (John Cunningham virus) test and either a REMS (for the U.S.) or RMP (for the EU) program, both of which will be subject to approval by the relevant health authority,” the company said. REMS stands for risk evaluation and mitigation strategy.

The FDA requires a REMS program for some drugs that typically includes monitoring for dangerous side effect. RMP stands for risk management plan and is similar set of requirements imposed on some drugs buy the European Medicines Agency.