FDA approves first natalizumab biosimilar Tyruko for MS

On 24 August 2023, the US Food and Drug Administration approved Tyruko (natalizumab-sztn) as the first biosimilar to Tysabri (natalizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko is first-of-its-kind biosimilar natalizumab to receive approval in the US.

This approval comes after Tyruko received a positive opinion from the European Committee for Medicinal Products for Human Use, recommending the granting of a marketing authorization, in July 2023 [1]. The application was first made in 2022 [2] and the biosimilar is being marketed by Sandoz and was developed by Polpharma Biologics, under the terms of a partnership created in 2019 [3].

Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of tumour necrosis factor-alpha (TNF-α) substance in your body that causes inflammation.

The originator, Tysabri (natalizumab), was developed by Biogen Idec and Elan and was first authorised in the European Union on 27 June 2006 [4]. 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) [5].

Tyruko is administered via injection and is indicated as monotherapy to treat all indications covered by the originator. This includes the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, and Crohn’s disease, in adults. This is the first biosimilar product indicated for treating relapsing forms of MS.

The approval was based on a robust data package that included phase I and phase III clinical studies [6]. Findings from the phase III Antelope study (ClinicalTrials.gov Identifier: NCT04115488) in relapsing remitting MS patients showed that the biosimilar product was equivalent in efficacy, safety, and immunogenicity to the reference product.

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first natalizumab biosimilar Tyruko for MS [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 15]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-natalizumab-biosimilar-tyruko-for-ms
2. 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 Sep 15]. Available from:
www.gabionline.net/biosimilars/news/applications-for-natalizumab-biosimilars-accepted-by-fda-and-ema
3. 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 Sep 15]. Available from:
www.gabionline.net/pharma-news/Sandoz-makes-deal-with-Polpharma-for-natalizumab-biosimilar
4. 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
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of natalizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 15]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-natalizumab
6. GaBI Online - Generics and Biosimilars Initiative. Phase III trials started for bevacizumab and natalizumab biosimilars[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 15]. Available from:
www.gabionline.net/biosimilars/news/Phase-III-trials-started-for-bevacizumab-and-natalizumab-biosimilars

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