Sandoz on Monday announced that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics. According to the company’s press statement, the application includes all indications covered by the reference medicine Tysabri (natalizumab) for relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults, and Crohn´s Disease.1
Meanwhile, the European Medicines Agency (EMA) also accepted the marketing authorization application (MAA) for this proposed biosimilar natalizumab, as announced on July 15, covering treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EMA for reference medicine Tysabri.
According to the generic pharmaceutical company, the submitted biosimilar was developed to have the same intravenous (iv) dosage form, route of administration, dosing regimen, and presentation as the reference medicine.
Multiple sclerosis is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system that can drastically affect an individual’s everyday life and requires life-long treatment.
“Thanks to advances in medicine over the last 20 years, we now have DMTs, which have become a cornerstone in the treatment of MS. However, access to affordable, high-quality treatment options is still a challenge. This is the first and only submission for a biosimilar natalizumab medicine in both the US and Europe. If approved, this biosimilar has the potential to increase access while also delivering savings for healthcare systems,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz.
“The BLA and MAA include a comprehensive analytical, preclinical, and clinical data package. The Phase I and Phase III Antelope studies in RRMS patients met their primary endpoints, showing that the biosimilar matches the reference medicine in terms of efficacy, safety, and immunogenicity. Sandoz is committed to all aspects of the safe use of, and patient experience with, its proposed biosimilar natalizumab. This includes a JCV test and either a REMS (for the US) or RMP (for the EU) program, both of which will be subject to approval by the relevant health authority,” it stated.