Bevacizumab similar biologics launched in India

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Bevacizumab similar biologics launched in India

Biosimilars/News | Posted 19/08/2016 0 Post your comment

Generics makers Reliance Life Sciences (Reliance) and Hetero have both launched similar biologics of Roche’s blockbuster cancer therapy Avastin (bevacizumab) in India.

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

The originator product, Swiss-based Roche’s Avastin had 2015 sales of CHF6.7 billion (US$6.9 billion). The patents on Avastin are set to expire in Europe in January 2022 and in the US in July 2019 [1].

Reliance announced on 10 June 2016 that its similar biologic had been approved for the treatment of colorectal cancer by India’s regulator, the Drug Controller General of India. The product will be marketed by Lupin under the name Bevacirel at a discount of around 25% compared to Avastin.

Hetero announced the approval of its similar biologic on 27 June 2016. Their product is also approved for the treatment of metastatic colorectal cancer and will be sold under the brand name Cizumab. Hetero’s bevacizumab marks the company’s third similar biologic, after darbepoetin alfa and rituximab.

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.

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Reference
1. Derbyshire M. Patent expiry dates for best-selling biologicals, Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040

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Source: Economic Times India, Hetero