FDA Accepts BLA for Tysabri Biosimilar

The FDA has accepted Sandoz’ biologics license application (BLA) for a first-of-a-kind biosimilar natalizumab, which references Biogen’s Tysabri. Sandoz, a subsidiary of Novartis, is seeking approval to treat patients with the relapsing forms of multiple sclerosis (MS), relapsing-remitting MS, active secondary progressive disease in adults, and Crohn´s Disease.

Sandoz’ biosimilar natalizumab, developed by Polpharma Biologics, has the same intravenous dosage form, route of administration, dosing regimen and presentation as Tysabri. Sandoz officials expect the review of the application to take about 12 months.

The European Medicines Agency (EMA) also accepted the marketing authorization application (MAA) for this proposed biosimilar natalizumab, covering treatment as a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting MS, the same indication as approved by the EMA for reference medicine Tysabri.

Both the FDA and EMA applications include data from the phase 1 and phase 3 Antelope studies in patients with relapsing-remitting MS. The studies met their primary endpoints, showing that the biosimilar matches the reference medicine in terms of efficacy, safety and immunogenicity.

“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,” Florian Bieber, global head of biopharmaceuticals development of Sandoz, said in a press release. “This is the first and only submission for a biosimilar natalizumab medicine in both the United States and Europe. If approved, this biosimilar has the potential to increase access while also delivering savings for healthcare systems.”

The price of the branded Tysabri is about $43,000 a year. Biosimilars generally launch at a price that is 30% lower.

Sandoz entered into a global commercialization agreement for proposed biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibility for development, manufacturing and supply.

MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system. It has a wide range of symptoms, including blurred vision, fatigue, weak limbs, unsteadiness and tingling sensations and leading to limited mobility and neurological decline.