Sandoz to Commercialize Biosimilar of MS Drug, Natalizumab

Sandoz, a Novartis division, announced today that it has entered into a global commercialization agreement with Poland-based Polpharma Biologics for a proposed natalizumab biosimilar referencing Biogen’s Tysabri.

Natalizumab is a disease-modifying therapy used to treat relapsing-remitting multiple sclerosis (MS) as well as Crohn disease. The monoclonal antibody is a selective adhesion molecule inhibitor that binds to α₄-integrin. Polpharma’s proposed biosimilar is currently in phase 3 clinical development for the treatment of MS.

Pierre Bourdage, ad interim global head of biopharmaceuticals at Sandoz, said in a statement, “Patient access to advanced medicines is important for all people diagnosed with a chronic disease, but the challenges are very pronounced for MS patients. By nature, biosimilars create competition and cost savings, which are proven to make room in healthcare systems to treat more patients.” He added that, with the agreement with Polpharma, Sandoz hopes to build on its experience with small-molecules and complex generics and to provide patients with expanded access to a disease-modifying treatment that they might otherwise be unable to access.

If it its eventually approved, the biosimilar of the high-cost natalizumab could bring some welcome relief to patients with MS who bear the burden of high—and continually increasing—costs for their therapies.

Just last week, a paper in JAMA Neurology reported that, for self-administered drugs for MS that are covered under the Medicare Part D benefit, the annual cost of treatment more than quadrupled from 2006 to 2016, from a mean of $18,660 to $75,847.¹ That increase resulted in a 7.2-fold increase in patient’s out-of-pocket costs. In an accompanying editorial, Daniel M. Hartung, PharmD, MPH, and Dennis Bourdette, MD, called on neurologists to be cognizant of the financial toxicity that MS therapies impart on patients, and they added that “Neurologists should be seeking to minimize the financial adverse effects of these therapies as much as they try to minimize physical adverse effects.”²

While natalizumab is an infused drug rather than a self-administered Part D drug, it too carries a substantial price tag. According to data derived from a review of MS therapies published by the Institute for Clinical and Economic Review in 2017, the brand-name natalizumab has a yearly wholesale acquisition cost of $78,214.

References

1. San-Juan-Rodriguez A, Good CB, Heyman RA, Parekh N, Shrank WH, Hernandez I. Trends in prices, market share, and spending on self-administered disease-modifying therapies for multiple sclerosis in Part D [published online August 26, 2019]. JAMA Neurol. doi:10.1001/jamaneurol.2019.2711.

2. Hartung DM, Bourdette D. Addressing the rising prices of disease-modifying therapies for multiple sclerosis [published online August 26, 2019]. JAMA Neurol. doi: doi:10.1001/jamaneurol.2019.2445.