Bevacizumab similar biologic launched in India

Biosimilares/Novedades | Posted 12/01/2018 post-comment0 Post your comment

India-based biologicals specialist Biocon announced on 23 November 2017 the launch of its product Krabeva, a ‘similar biologic’ of bevacizumab, in India.

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Krabeva is a similar biologic of Roche’s blockbuster cancer drug Avastin (bevacizumab), which was approved by the US Food and Drug Administration (FDA) in February 2004 and by the European Medicines Agency (EMA) in January 2005 [1]. Avastin is indicated for the treatment of non-small cell lung cancer (NSCLC), colorectal cancer, renal cell cancer, ovarian cancer and breast cancer.

Biocon says that Krabeva has been approved in India for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers.

The launch of Krabeva follows the successful completion of phase III clinical trials and approval of Biocon’s Marketing Authorization Application by the Drug Controller General of India (DCGI). The drug product is Biocon’s second oncologic similar biologic to be launched in India. Biocon has also marketed a breast cancer similar biologic, CanMab (trastuzumab) since 2013 [2].

Biocon also points out that Krabeva ‘is the world´s first and only bevacizumab with a unique ‘Qual­Check’ mechanism, which will ensure that patients get a quality-ascertained product right up to infusion’.

The company has already carried out a three-way phase I pharmacokinetics study in healthy volunteers in Europe. It is also carrying out a global phase III trial in NSCLC patients at more than 100 sites across multiple countries using a European Union and US sourced reference product.

Editor’s comment
It should be noted that ‘similar biologics’ approved in India 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.

Related articles
Biosimilars of bevacizumab

‘Similar biologics’ approved and marketed in India

References
1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab ‘similar biologic’ to be launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-similar-biologic-to-be-launched-in-India

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Source: Biocon

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