Trastuzumab Biosimilar, Hervycta, Launches in India

A new trastuzumab (Herceptin) biosimilar has launched in India. Dr Reddy’s Laboratories, the developer of the biosimilar, indicated that the drug will be sold under the name Hervycta, and that it has been approved in India to treat HER2-postive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

“The launch of Hervycta will immensely benefit women in India who are suffering from HER2-positive breast cancer and are in need of access to high-quality, affordable, and innovative medicines,” said Raymond De Vré, senior vice president and head of biologics at Dr Reddy’s Laboratories, in a statement.

Biosimilar trastuzumab is Dr Reddy’s 4th biosimilar to be commercialized in India and in various other emerging markets. Other biosimilars developed by the company include darbepoetin alfa, sold as Cresp; filgrastim, sold as Grafeel; pegfilgrastim, sold as Peg-grafeel; and rituximab, sold as Reditux.

Herceptin sales in 2017 were reported as growing 5.7%, to $57 billion, beating the expectations of analysts. In the European Union, there are currently 3 trastuzumab biosimilars on the market, sold as Ontruzant, Herzuma, and Kanjinti. Although the United States has approved 1 trastuzumab biosimilar, Ogivri, it has yet to reach the market.

In India, while regulatory standards differ from those in the United States, the biosimilar space is comparatively well-established. According to Generics and Biosimilars Initiative (GaBI), the first “similar biologic” was approved and marketed in India in 2000, or 15 years before the first approval in the United States. Drug makers in India are motivated in part by the government’s initiative to offer subsidies to biosimilar manufacturers. In 2017, an analysis conducted by Decision Resources Group (DRG) found that more than 40 biosimilars were in clinical development in India, far more than are currently being developed in the United States.

The Indian market also sees faster approvals and shorter review periods than other regulatory districts due to factors such as high discounting and reduced patent protections for innovator drugs.

“We strive every day to do what matters most for our patients. Hervycta is a step forward in our effort to accelerate access to cancer patients in India, in the oncology biosimilar space,” said MV Ramana, the CEO of branded markets at Dr. Reddy’s laboratories.