FDA Approves Natalizumab For Sandoz And Polpharma Biologics

Sandoz and Polpharma Biologics are celebrating the second major regulatory nod for their biosimilar rival to Biogen’s Tysabri (natalizumab), after the pair’s partnered Tyruko (natalizumab-sztn) version received US Food and Drug Administration approval.

Developed by Polpharma Biologics, the biosimilar saw its global commercialization rights licensed to Sandoz under a 2019 deal.

Noting that Tyruko had been approved for “all indications of the reference medicine, with the same dosing and administration schedule,” Sandoz said it would “continue to expand access to much-needed medications for patients in US, offering another treatment option to help control relapsing forms of multiple sclerosis.” Approved indications for Tyruko cover relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease, as well as Crohn’s disease in adults.

The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval of Tyruko last month. A formal European approval and marketing authorization is expected within weeks. (Also see "Triple Threat: EMA Endorses Three First-Time Biosimilars" - Generics Bulletin, 21 Jul, 2023.)

Tysabri represents a significant target for Sandoz, with Biogen reporting global sales of $2.03bn in 2022 – with more than half of this figure, $1.12bn, coming in the US alone – and no other biosimilar rivals on the horizon.

As such, Sandoz global head of biosimilars Peter Stenico recently told Generics Bulletin that Tyruko had the potential to become an enduring asset for Sandoz, similar to its long-established Omnitrope (somatropin) biosimilar.

Stenico said the natalizumab biosimilar had the potential to “evolve into that kind of story, where we are the only one with 17 years on the market.”

Due to the complexity of the product, “nobody that we know of is really in development,” Stenico outlined. “We will hopefully be the only one for a very long time. And we will shape that market” (see sidebar).

Polpharma Biologics CEO Michael Soldan also highlighted the significance of the product in a recent interview with Generics Bulletin, acknowledging that while Sandoz holds global commercialization and distribution rights for the product, “upon approval, we’ll work closely with Sandoz to help bring biosimilar natalizumab to patients as quickly as possible.” (Also see "Polpharma Biologics CEO Discusses Natalizumab Milestone" - Generics Bulletin, 10 Aug, 2023.)

Commenting on the FDA approval, Sandoz North America president Keren Haruvi said that “of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.”

“The FDA granted approval based on a robust data package, including analytical, functional and clinical data,” Sandoz noted, adding that the approval was “accompanied by labeling with safety warnings and a Risk Evaluation and Mitigation Strategy.”

“Tyruko has the same intravenous dosage form, route of administration, dosing regimen and presentation as the reference medicine,” Sandoz noted, underlining that it was “dedicated to all aspects of patient safety with Tyruko, which, upon launch, will be available through the Sandoz REMS program.”

While the firm did not elaborate on launch plans, it said it was “committed to bringing this important medicine to US patients as soon as possible.”

The approval is a further positive development for Sandoz ahead of its upcoming spinoff from parent company Novartis. (Also see "Sandoz Sets Date For Spinoff" - Generics Bulletin, 21 Aug, 2023.) The firm’s biosimilars interests have been highlighted as a major strategic focus ahead of the separation. (Also see "Biosimilars Loom Large As Sandoz Sets Stage For Spinoff" - Generics Bulletin, 19 Jun, 2023.)

“The FDA’s approval of Tyruko means clinicians will soon have access to an affordable treatment that can change the lives of people with relapsing MS.”

Commenting on the approval, Polpharma Biologics CEO Soldan highlighted the potential savings from the natalizumab biosimilar.

“Targeted therapies are the cornerstone of care for people with MS, but high medication prices are fueling access issues and healthcare expenditure,” Soldan observed. “The need to address the rising costs of this devastating disease to patients and societies inspired the scientific teams at Polpharma Biologics to develop an efficacious MS biosimilar.”

“We are delighted that the FDA’s approval of Tyruko means clinicians will soon have access to an affordable treatment that can change the lives of people with relapsing MS.”

The FDA also highlighted the natalizumab approval as the first biosimilar approved to treat MS.

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis,” said Paul Lee, director of the division of neurology in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”

Meanwhile Sarah Yim, director of the CDER’s Office of Therapeutic Biologics and Biosimilars, said the approval “furthers the FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”