A New Hope for Patients with MS – The First FDA-Approved Biosimilar  

A major milestone in the management of multiple sclerosis (MS) was achieved with the recent FDA approval of its biosimilar. The biosimilar, natalizumab-sztn, is the first of its kind, modeled from the already approved monoclonal antibody treatment, natalizumab. The new disease-modifying treatment provides a more affordable option for patients with relapsing forms of MS, thus increasing the accessibility for patients with relapsing forms of MS and Crohn’s disease.

Natalizumab-sztn is indicated for clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease, and is also indicated for moderate to severely active Crohn’s disease in adults. Studies showed no clinically meaningful differences between the natalizumab-sztn  and its reference product, natalizumab.

Safety and Efficacy
It’s suggested that natalizumab-sztn  can be a game changer for patients with MS and Crohn’s, especially for ones that have been unable to tolerate or are unresponsive to conventional treatments. The expected safety and efficacy of the biosimilar is that of the biologic, so patients and healthcare professionals can anticipate similar reductions in the number of relapses along with a similar time frame to disability progression. Further in terms of safety, similar risks can be expected including progressive multifocal leukoencephalopathy (PML), so following a REMS program will also be required.

The characteristics of the Phase III clinical trial evaluating the safety and efficacy of natalizumab-sztn are:

• Study design: Parallel-group, randomized, active-controlled, double-blind, quadruple masked; international, multisite; Patients 18-60 years of age with relapsing forms of MS
• Interventions: 300 milligrams of the biosimilar or the reference product for 48 weeks with an additional rerandomization switch for 30 patients initially on the reference product at week 24
• Outcomes Measures: Cumulative number of new active and persistent brain lesions, annual relapse rate, time to disability, safety, tolerability, and immunogenicity

Conclusions:

• Efficacy: Non-inferiority in terms of number of relapses and time to disability progression
• Safety and tolerability: Similar safety profiles with no new or increased risks and not dissimilar immunogenicity
• Limitations: Small sample size (264 patients)

Collectively, the safety and efficacy of natalizumab-sztn have been demonstrated in clinical studies. This newly approved biosimilar has the potential to provide renewed hope in patients with relapsing forms of MS and Crohn’s disease as a treatment option with increased accessibility and affordability.

REFERENCES

1.         FDA Approves First Biosimilar to Treat Multiple Sclerosis. Press Announcements. Published August 24, 2023. Accessed August 25, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-multiple-sclerosis

2.         Hemmer B, Wiendl H, Roth K, et al. Efficacy and Safety of Proposed Biosimilar Natalizumab (PB006) in Patients With Relapsing-Remitting Multiple Sclerosis: The Antelope Phase 3 Randomized Clinical Trial. JAMA Neurol. 2023;80(3):298-307. doi:10.1001/jamaneurol.2022.5007