Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA

Sandoz 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.

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.

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.

The submitted biosimilar was developed to have the same intravenous dosage form, route of administration, dosing regimen and presentation as the reference medicine.

MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system (brain and spinal cord)  that can drastically affect an individual’s everyday life and requires life-long treatment. The disease has a wide range of symptoms, beginning with blurred vision, fatigue, weak limbs, unsteadiness and tingling sensations and leading to limited mobility and neurological decline. Treatment cost and lack of access to effective treatment can create an additional burden for people with MS, their families and healthcare systems.

“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,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. “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.”

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.

Sandoz entered into a global commercialization agreement for proposed biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibility for development, manufacturing and supply. Through an exclusive global license, Sandoz has the rights to commercialize and distribute the product in all markets.

Sandoz is committed to helping millions of patients access biologic medicines sustainably in many different disease areas, including oncology and immunology. These submissions build on the already approved and well-established Sandoz global portfolio of eight marketed biosimilars and a further 15+ in various stages of development.