The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for marketing authorization for the first-of-its-kind biosimilar natalizumab developed by Polpharma Biologics, according to Sandoz, a global leader in off-patent (generic and biosimilar) medications.
In adults with highly active relapsing-remitting multiple sclerosis (RRMS), the authorisation includes treatment as a single disease-modifying therapy (DMT), the same indication as was authorised by the EMA for the reference biologic.
In 2019, Sandoz and Polpharma Biologics signed a global commercialization deal for the biosimilar natalizumab. As per the terms of the agreement, Polpharma Biologics will continue to be in charge of drug substance production, development, and supply. Sandoz has the sole right to commercialise and distribute it across all markets thanks to a worldwide licence.
“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,” – said Pierre Bourdage, Chief Commercial Officer of Sandoz.
The CHMP’s favourable conclusion released today is unquestionably a step in the right direction for addressing the disease’s burden on people with multiple sclerosis while also generating cost savings for healthcare systems.The thorough analytical, preclinical, and clinical data regulatory filing package comprised data from a Phase I PK/PD study, a confirmatory Phase III Antelope study in RRMS patients, as well as evidence from a rigorous analytical characterization. The key objectives of both studies were satisfied, demonstrating that the biosimilar is an exact match for the reference biologic in terms of pharmacokinetics, effectiveness, safety, and immunogenicity.
About Multiple Sclerosis:
The central nervous system (brain and spinal cord) is affected by the chronic, inflammatory, and neurodegenerative disease known as multiple sclerosis (MS), which is brought on by myelin degradation. It requires lifelong care and can have a significant impact on a person’s daily life. Wide-ranging MS symptoms include impaired vision, fatigue, limb weakness, unsteadiness and tingling during the outset, limited movement, communication and breathing problems, and neurological decline at later stages. People with MS, their families, and healthcare systems may experience additional stress and financial strain due to the high cost of treatment and limited access.
