On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Tyruko (natalizumab), a biosimilar of reference product Tysabri, intended for the treatment of multiple sclerosis (MS).
The originator product, Biogen Idec and Elan’s Tysabri, was first authorised in the EU on 27 June 2006 [1]. The applicant for this medicinal product, Sandoz GmbH, is working in partnership with the drug product developer Poland-based Polpharma Biologics [2]. The Tyruko biosimilar drug applications were accepted by the US Food and Drug Administration and European Medicines Agency (EMA) in 2022 [3].
If approved, Tyruko will be first-of-a-kind biosimilar natalizumab in Europe, for use in all indications of reference biological.
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 MS (US and Europe) and Crohn’s disease (US) [4].
The positive CHMP opinion is based on evidence from extensive analytical characterization confirming similarity of biosimilar with reference biological, in addition to phase I and confirmatory phase III studies in relapsing-remitting multiple sclerosis (RRMS) patients.
Of this positive opinion, Pierre Bourdage, Chief Commercial Officer, Sandoz, said: ‘Access to affordable, high-quality treatments like disease-modifying therapies – which are a cornerstone in the treatment of multiple sclerosis – remains limited for many people living with this disease. Today’s positive opinion from the CHMP is a clear step in the right direction to address the burden of the disease for those living with multiple sclerosis while also delivering savings for healthcare systems.’
The authorization covers treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by EMA for the reference biological.
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Sandoz makes deal with Polpharma for natalizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from: www.gabionline.net/pharma-news/Sandoz-makes-deal-with-Polpharma-for-natalizumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Applications for natalizumab biosimilars accepted by FDA and EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from:
www.gabionline.net/biosimilars/news/applications-for-natalizumab-biosimilars-accepted-by-fda-and-ema
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of natalizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-natalizumab
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