- If approved, it will be first-of-a-kind biosimilar natalizumab in Europe, for use in all indications of reference biologic
- Positive CHMP opinion is based on evidence from extensive analytical characterisation confirming similarity of biosimilar with reference biologic, in addition to Phase I and confirmatory Phase III studies in RRMS patients
July 24, 2023 — Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorisation for first-of-a-kind biosimilar natalizumab developed by Polpharma Biologics.
The authorisation covers treatment as a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS), the same indication as approved by the EMA for the reference biologic.1
Sandoz entered into a global commercialisation agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing, and supply of drug substance. Through an exclusive global license, Sandoz has the rights to commercialise and distribute it in all markets.
Access to affordable, high-quality treatments like disease-modifying therapies – which are a cornerstone in the treatment of multiple sclerosis – remains limited for many people living with this disease. At Sandoz, we are committed to accelerating access to potentially life-changing treatments to patients in need around the world. Today’s positive opinion from the CHMP is a clear step in the right direction to address the burden of the disease for those living with multiple sclerosis while also delivering savings for healthcare systems.Pierre Bourdage, Chief Commercial Officer
The comprehensive analytical, preclinical, and clinical data regulatory submission package included evidence derived from an extensive analytical characterisation, in addition to results from a Phase I PK/PD study and a confirmatory Phase III Antelope study in RRMS patients. Both studies met their primary endpoints, showing that the biosimilar matches the reference biologic in terms of pharmacokinetics as well as efficacy, safety and immunogenicity.
- European Medicines Agency (EMA). Tysabri EPAR. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/Tysabri [Accessed April 2023]
- MS International Federation. What is MS? October 2021. Available from: https://www.msif.org/about-ms/what-is-ms [Accessed April 2023]
- Mayo Clinic. About Multiple Sclerosis. 2022. Available from: https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269 [Accessed April 2023]
- Research Outreach. The Financial Toxicity of Multiple Sclerosis. August 2021. Available from: https://researchoutreach.org/articles/financial-toxicity-multiple-sclerosis [Accessed April 2023]