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Clinical trials for trastuzumab biosimilars Posted 28/08/2020

Roche’s originator trastuzumab biological (Herceptin) was approved by the US Food and Drug Administration (FDA) in September 1998 and by the European Medicines Agency (EMA) in August 2000 [1]. The patents on Herceptin expired in Europe in July 2014 and in the US in June 2019 [1]. This has led to biosimilars of trastuzumab being developed.

Many companies have already developed trastuzumab biosimilars [2]. These include major players such as South Korean biotechnology company Celltrion, which gained European Commission approval for its trastuzumab biosimilar Herzuma (CT P6) in February 2018 [3] and FDA approval in December 2018 [4].

In order to gain regulatory approval for biosimilars a package of data that includes analytical, non-clinical and clinical data is required. To demonstrate biosimilarity for regulatory approval, clinical trials of biosimilars need to be carried out.

As of 30 March 2020, 19 clinical trials relevant to trastuzumab biosimilar development covering 13 different candidate biosimilars and non-originator biologicals are being, or have been, carried out for trastuzumab biosimilars.

An overview of these clinical trials for trastuzumab is given in a GaBI Journal article [5].

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Pivotal clinical trials for trastuzumab biosimilars

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. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Aug 28]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Herzuma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Aug 28]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Herzuma
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Herzuma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Aug 28]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Herzuma
5. Derbyshire M. Clinical trials for trastuzumab biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(2):84-9. doi:10.5639/gabij.2020.0902.014

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Source: ClinicalTrials.gov, EU Clinical Trials Register

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