Applications for natalizumab biosimilars accepted by FDA and EMA

Biosimilares/Novedades | Posted 09/09/2022 post-comment0 Post your comment

Applications for natalizumab biosimilars made by Sandoz (the generics division of Novartis) and Polpharma Biologics (Polpharma) have been accepted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

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Sandoz and Polpharma announced on 25 July 2022 that FDA had accepted the biologics license application (BLA) for their proposed first-of-a-kind biosimilar natalizumab.

The biosimilar was developed by Poland-based Polpharma Biologics. Sandoz and Polpharma signed a worldwide agreement in September 2019 giving Sandoz commercialization rights to Polpharma’s candidate natalizumab biosimilar (PB006) [1]. PB006 is a proposed biosimilar of Biogen Idec and Elan’s Tysabri (natalizumab), which had worldwide sales of US$2.1 billion in 2021 [2].

Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin. Natalizumab is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier. Natalizumab is indicated for the treatment of multiple sclerosis (US and Europe) and Crohn’s disease (US).

The biosimilar application includes all indications covered by the reference medicine Tysabri for relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome, relapsing-remitting MS (RRMS), active secondary progressive disease in adults, and Crohn’s disease [3].

The companies also announced that EMA has also accepted the marketing authorization application for this proposed biosimilar natalizumab covering treatment as a single disease-modifying therapy in adults with highly active RRMS, the same indication as approved by EMA for reference medicine Tysabri [4].

The applications are based on a comprehensive analytical, preclinical and clinical data package. The phase I and phase III Antelope studies in RRMS patients [5] 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 John Cunningham virus (JCV) test and either a risk evaluation and mitigating strategies (REMS) (for the US) or risk management plan (RMP) (for the EU) programme, both of which will be subject to approval by the relevant health authority.

This is the first and only submission for a biosimilar natalizumab medicine in both Europe and the US. According to Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz, ‘if approved, this biosimilar has the potential to increase access while also delivering savings for healthcare systems’.

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1. GaBI Online - Generics and Biosimilars Initiative. Sandoz makes deal with Polpharma for natalizumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 9]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of natalizumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 9]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 9]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 9]. Available from:

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Source: Novartis, Polpharma Biologics, Sandoz

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