Biogen’s Tysabri was first approved in the EU in 2006 as an intravenous formulation, while a subcutaneous formulation was approved last year. The drug made close to $2.1bn worldwide in 2021: making it one of the top-sellers for the company.
Phase 3 data supports application
The EMA application for natalizumab is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as reference medicine Tysabri - a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS).
The application was supported by analytical, preclinical and clinical data, including that from the Phase 3 Antelope study in RRMS patients. This study met its primary endpoints, ‘demonstrating that the proposed biosimilar matched the efficacy and safety of the reference medicine’, according to the company.
Natalizumab was developed by Polpharma Biologics and the company retains responsibility for the manufacturing and supply of the medicine. Sandoz has the rights to commercialize and distribute the proposed biosimilar under an exclusive global license, secured through a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019.
“The acceptance of the filing of proposed biosimilar natalizumab by the European regulatory authorities means we are a critical step closer to getting this important medicine to the patients who need it the most. We are deeply proud of the dedication of our scientific teams to take biosimilar natalizumab from cell line and technical development, through clinical trials to registration - this milestone is testament to their achievements,” said Michael Soldan, CEO.
MS is a chronic inflammatory and neurodegenerative disease. Up to half of all patients need to withdraw from employment within a decade of their diagnosis, need assistive walking devices within 15 years and are unable to walk 25 years after diagnosis. Due to the high cost of therapies, the economic burden of MS is substantial - estimated at up to €57,000 ($58,000) per patient, per year in those with moderate-to-severe disease.
Eyes also on Lucentis biosimilar ranibizumab
Natalizumab is the second proposed biosimilar from Polpharma’s pipeline to be successfully filed in Europe over the past year, following the submission of ranibizumab, a biosimilar to Genentech’s Lucentis. This biosimilar has also been accepted for review in the US by the FDA and approved by the UK’s MHRA.
Other biosimilars in Polpharma's pipeline include another MS biosimilar Ocrelizumab (biosimilar to Ocrevus) and Vedolizumab (biosimilar to Entyvio).