Biogen’s Tysabri was first approved in the EU as an intravenous formulation in 2006, while a subcutaneous formulation was approved last year. The drug made nearly $2.1 billion worldwide in 2021, making it one of the company’s best-selling products.
Phase 3 Data Support Application
The EMA application for natalizumab is for an intravenous (IV) route of administration, with the same dosage regimen, presentation and indication as the reference drug 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 those from the Phase 3 Antelope study in RRMS patients. This study met the primary endpoints, “demonstrating that the proposed biosimilar was consistent with the efficacy and safety of the reference drug,” the company said.
Natalizumab was developed by Polpharma Biologics and the company remains responsible for manufacturing and supplying the drug. Sandoz has the rights to commercialize and distribute the proposed biosimilar under an exclusive worldwide license, secured by a commercialization agreement signed in 2019 between Polpharma Biologics and Sandoz.
“The acceptance of the submission of the proposed biosimilar natalizumab by the European regulatory authorities means we are a crucial step closer to getting this important drug to the patients who need it most. We are extremely 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 a testament to their achievements.”said Michael Soldan, CEO.
MS is a chronic inflammatory and neurodegenerative disease. Up to half of all patients must retire within 10 years of their diagnosis, require walking aids within 15 years, and are unable to walk for 25 years after diagnosis. Due to the high cost of therapies, the economic burden of MS is significant – estimated at up to €57,000 ($58,000) per patient, per year in people with moderate to severe disease.
Eyes also on Lucentis biosimilar ranibizumab
Natalizumab is the second proposed biosimilar from Polpharma’s pipeline to be successfully submitted in Europe over the past year, following the submission of ranibizumab, a biosimilar of Genentech’s Lucentis. This biosimilar has also been accepted for review in the US by the FDA and approved by the UK MHRA.
Other biosimilars in Polpharma’s pipeline include another MS biosimilar Ocrelizumab (biosimilar for Ocrevus) and Vedolizumab (biosimilar for Entyvio).