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Biosimilar trastuzumab candidates in phase III development

Biosimilars/Research | Posted 09/05/2014 0 Post your comment

The introduction of Herceptin (trastuzumab) revolutionalized the treatment of breast cancer. Prior to its introduction there were few treatment options available to women with human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

With the expiry of the patent on Herceptin expected on 28 July 2014 [1] it is not surprising that several biosimilar trastuzumab candidates are currently in development [2]. Of these, CT-P6, from South Korean biotechnology company Celltrion, is the furthest along in the clinical development pathway. Biosimilar trastuzumab candidates in phase III development are shown in Table 1.

Table 1: Trastuzumab biosimilars and non-originator biologicals in phase III development

Company name	Product name	ClinicalTrials.gov identifier/ EudraCT number	Condition	Primary endpoint	Status
Actavis/ Amgen/ Synthon	ABP-980	NCT01901146	Breast cancer	Pathologic complete response	Expected completion date: December 2016
Biocad*	BCD-022	NCT01764022	Metastatic breast cancer	Overall response rate	Expected completion date: November 2014
Biocon/ Mylan*	CANMAb/ Hertaz	N/A	Metastatic breast cancer	N/A	Similar biologic approved in India [3, 4]
Celltrion	CT-P6	NCT01084876 2013-004525-84	Metastatic breast cancer HER2+ operable early breast cancer	Overall response rate Pathological complete response	Completed Ongoing [5] Herzuma (CT-P6) approved in South Korea [6]
Pfizer	PF-05280014	N/A	Metastatic breast cancer	N/A	Planned. Phase I study completed [7]
HER2+: human epidermal growth factor receptor 2-positive; N/A: not applicable *See editor’s comment

Celltrion received approval for its biosimilar monoclonal antibody (mAb) Herzuma (trastuzumab) with the Korean Ministry of Food and Drug Safety (formerly the Korea Food and Drug Administration) in January 2014 [6]. This makes it most likely to be the first company to gain European approval for a biosimilar trastuzumab.

Roche’s worldwide sales of Herceptin in 2013 were CHF 6.1 billion (US$6.8 billion) making it a lucrative target for biosimilars manufacturers.

Herceptin has been hailed as a wonder drug by doctors, but the only problem is that treating a patient for one year with Herceptin costs the UK National Health Service (NHS) GBP 21,800. It has therefore, until now, only been available on the NHS for women in the later stages of breast cancer. The arrival of biosimilars could hopefully pave the way for more patients to gain access to the drug at an earlier stage of the disease, thus improving survival rates.

Editor’s comment
It should be noted that ‘similar biologics’ approved in India and ‘non-originator biologicals’ approved in Russia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Biosimilars approved in South Korea

References
1. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www:gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
2. Cortés J, Curigliano G, Diéras V. Expert perspectives on biosimilar monoclonal antibodies in breast cancer. Breast Cancer Res Treat. 2014;144(2):233-9.
3. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab ‘similar biologic’ to be launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-similar-biologic-to-be-launched-in-India
4. GaBI Online - Generics and Biosimilars Initiative. Mylan launches trastuzumab ‘similar biologic’ in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Biosimilars/News/Mylan-launches-trastuzumab-similar-biologic-in-India
5. GaBI Online - Generics and Biosimilars Initiative. Celltrion starts phase III biosimilar trastuzumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-starts-phase-III-biosimilar-trastuzumab-trial
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea
7. GaBI Online - Generics and Biosimilars Initiative. Robust data for biosimilar trastuzumab programmes presented [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Biosimilars/Research/Robust-data-for-biosimilar-trastuzumab-programmes-presented

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