Polpharma Biologics announces EMA acceptance of Marketing Authorization Application for proposed biosimilar natalizumabPublished: 14.07.2022
Amsterdam, The Netherlands, 14th of July 2022
Polpharma Biologics, an international biotech company dedicated to the development of biosimilars, announced today that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to Tysabri®*. The application is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as the reference medicine Tysabri® - a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS).1
“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 - today’s milestone is testament to their achievements,” said Michael Soldan, CEO. “Natalizumab is the second proposed biosimilar from our pipeline following ranibizumab** to have been successfully filed in Europe in the past year, showing the strength and depth of our product portfolio.”
About Polpharma Biologics
*Tysabri® is a registered trademark of Biogen MA, Inc.
** A biosimilar ranibizumab (biosimilar to Lucentis®) developed through Bioeq AG, joint venture company of Polpharma Biologics and Formycon, currently under review by the FDA and EMA. Lucentis® is a registered trademark of Genentech Inc.
1. European Medicines Agency (EMA). Tysabri EPAR. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/Tysabri [Accessed June 2022]
2. Cohen JA, Rudick RA. Aspects of multiple sclerosis that relate to trial design and clinical management. In: Cohen JA, Rudick RA, Third ed. Multiple sclerosis therapeutics. Boca Raton, FL: Taylor & Francis, 2007
3. Kobelt G, Thompson A, Berg J, et al. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler. 2017;23(8):1123-1136. doi:10.1177/1352458517694432
4. Hemmer B, Wiendl H, Roth K, et al. Efficacy and safety of proposed natalizumab biosimilar PB006 versus Tysabri® in patients with relapsing remitting multiple sclerosis: Primary data from the Phase III Antelope study (P6-4.003). Neurology. May 03, 2022; 98 (18 Supplement https://n.neurology.org/content/98/18_Supplement/1103)