Trastuzumab similar biologic Hervycta launched in India

Biosimilars/News | Posted 02/11/2018 post-comment0 Post your comment

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 July 2018 the launch of its product Hervycta, a ‘similar biologic’ of trastuzumab, in India.


Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast and gastric cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably.

Hervycta is a similar biologic of Roche’s blockbuster breast cancer drug Herceptin (trastuzumab), which was approved by the US Food and Drug Administration (FDA) in September 1998 and by the European Medicines Agency (EMA) in August 2000 [1]. Herceptin is indicated for the treatment of breast and gastric cancers.

Dr Reddy’s said that it is approved for the treatment of HER2-positive cancers (early breast cancer, metastatic breast cancer and metastatic gastric cancer).

Herceptin (marketed as Herclon in India) and its similar biologics had India sales of approximately INR 290 Crore MAT in 2017, according to Ipsos.

Dr Reddy’s has four other similar biologics commercialized in India and various emerging markets. These include Cresp (darbepoetin alfa), Grafeel (filgrastim), Peg-grafeel (pegfilgrastim) and Reditux (rituximab). The company also says that it has an active pipeline of several similar biologics in the oncology and immunology space.

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1. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007

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Source: Dr Reddy’s

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