Biosimilar Trastuzumab (Hertraz) Approved in India

Zosia Chustecka


November 27, 2013

A biosimilar version of the breast cancer targeted therapy trastuzumab (Herceptin, Genentech/Roche) has been approved in India.

Trastuzumab is used in the treatment of HER2-positive breast cancer (around 25% of all breast cancer).

The new biosimilar product will be marketed under the trade name Hertraz by Mylan and as CANMAb by Biocon.

The 2 companies have coexclusive rights with for the product in India, and they plan to launch the drug in early 2014. "We look forward to bringing a high-quality, affordable product to patients in India who need it," they said in a statement.

The approval of what is essentially a generic version of the targeted drug comes 3 months after Roche's patent on Herceptin expired in India, notes a report in the International Business Times.

"This is a major milestone for both partners as it is the world's first biosimilar trastuzumab to be accorded regulatory approval," commented Kiran Mazumdar Shaw, chair and managing director at Biocon. "The Indian approval is an encouraging milepost as we plan to leverage these data to support regulatory filings in several countries across the globe," he said in a statement.

Biocon noted that global sales of trastuzumab were US$6.4 billion in 2012, and sales in India were around $21 million.

Mylan has exclusive commercialization rights for the biosimilar trastuzumab product in Australia, Canada, the European Union, Japan, New Zealand, and the United States, and in European Free Trade Association countries.

Herceptin was first launched 1998. Currently in the United States, treatment with this drug costs around $4500 per month. The manufacturers, Genentech/Roche, have developed 2 more HER2-targeted agents, pertuzumab (Perjeta), launched in 2012, which costs around $6000 per month, and most recently ado-trastuzumab emtansine (Kadcyla), which costs around $9800 per month in the United States.


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