Trastuzumab biosimilar from Prestige accepted for review by EMA

Biosimilars/News | Posted 14/06/2019 post-comment0 Post your comment

Singapore-based Prestige BioPharma (Prestige) announced on 28 May 2019 that the regulatory submission for its proposed trastuzumab biosimilar Tuznue (HD201) had been accepted by the European Medicines Agency (EMA).

Trastuzumab Herceptin V13D12

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

The product is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had worldwide sales of CHF 7.0 billion (US$ 7.5 billion) in 2017, before the advent of biosimilars. The patents on Herceptin expired in Europe in July 2014 and in the US in June 2019 [1].

Prestige is seeking approval for its biosimilar in the same indications as the reference product (Herceptin). In addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials, the submission includes data from Prestige’s phase I/III global clinical trial of HD201. This trial, according to the company, ‘confirms that HD201 is exceptionally similar to Herceptin in terms of clinical response and PK [pharmacokinetic]’.

This will be Prestige’s first biosimilar to be approved in the European Union. There are already five other trastuzumab biosimilars approved in Europe, including Celltrion’s Herzuma, Amgen’s Kanjinti, Biocon/Mylan’s Ogivri, Ontruzant from Samsung Bioepis and Pfizer’s Trazimera [2].

Prestige also plans to submit its trastuzumab biosimilar to the US Food and Drug Administration (FDA) by the end of 2019. The company is working on a bevacizumab biosimilar (HD204), which is in phase III and an adalimumab biosimilar (PBP1502), which is in phase I [3, 4].

Source: Prestige BioPharma

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1. Derbyshire M. Patent expiry dates for best-selling biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 14]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 14]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 14]. Available from:

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Source: Prestige BioPharma

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