India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 19 August 2019 that it had launched its bevacizumab ‘similar biologic’, Versavo (DRZ_BZ) in India.
Bevacizumab ‘similar biologic’ Versavo launched in India
Biosimilars/News | Posted 08/11/2019 0 Post your comment
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, Switzerland-based Roche’s Avastin had 2016 sales of CHF 6.8 billion (Euros 5.95 billion), before the advent of biosimilars. The patents on Avastin expired in the US in July 2019 and will expire in Europe in 2020 . Avastin and its biosimilars had India sales of approximately INR 223 Crore MAT for the 12 months ending December 2018, according to Ipsos.
Versavo has been approved in India in strengths of 100 mg and 400 mg. It is indicated for the treatment of several types of cancers, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer.
Three other bevacizumab ‘similar biologics’ have already been launched in India. Reliance Life Sciences (Reliance) and Hetero launched Bevacirel and Cizumab, respectively, in June 2016. Biocon launched Krabeva in November 2017 .
Dr Reddy’s now has six similar biologics commercialized in India and various emerging markets. As well as Versavo, these include Cresp (darbepoetin alfa), Grafeel (filgrastim), Hervycta (trastuzumab), Peg-grafeel (pegfilgrastim) and Reditux (rituximab). The company also states that it has ‘an active development pipeline of several biosimilar products in the oncology and immunology space’.
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.
Biosimilars of bevacizumab
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. Bevacizumab similar biologics launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 4]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-similar-biologics-launched-in-India
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Source: Dr Reddy’s