Sandoz, a global pharmaceutical company working in generics and biosimilars, announced this week that the US Food and Drug Administration (FDA) has accepted its biologic application (BLA) for the treatment of people with multiple sclerosis (MS).
The application concerns a biosimilar natalizumab developed by Polpharma Biologics and covers all indications covered by the reference medicine Tysabri (natalizumab) for relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults and Crohn’s disease.
biosimilar
The European Medicines Agency (EMA) also accepted the Marketing Authorization Application (MAA) for this proposed biosimilar natalizumab for treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the European Medicines Agency (EMA). EMA as reference medicine Tysabri (a registered trademark of Biogen).
Tysabri is designed to have the same intravenous (iv) dosage form, route of administration, dosing schedule and presentation as the reference drug.
MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system (brain and spinal cord) 3 that can drastically affect a person’s daily life and requires lifelong treatment. The disease has a wide range of symptoms, starting with blurred vision, fatigue, weak limbs, unsteadiness and tingling and leading to limited mobility and neurological decline.4 The cost of treatment and lack of access to effective treatment can place additional burdens on people with disabilities. MS, their families and health care systems.
Patient access
Sandoz says it is committed to accelerating patients’ access to potentially life-changing, high-quality treatments, while delivering savings for healthcare and patients.
Florian Bieber, Global Head of Biopharmaceuticals Development, at Sandoz said: “Thanks to advances in medicine over the past 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 drug in both the US and Europe. If approved, this biosimilar has the potential to increase access while delivering savings to healthcare.”
The BLA and MAA comprise a comprehensive analytical, preclinical and clinical data package. The Phase 1 and Phase 3 antelope studies in RRMS patients met their primary endpoints, demonstrating that the biosimilar is comparable to the reference drug in terms of efficacy, safety and immunogenicity.
Approval
The company says it is committed to all aspects of the safe use and patient experience of 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 are 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 remains responsible for development, manufacturing and supply.