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Biocon plans February launch for first biosimilar Herceptin

Set to market own version of breast cancer drug in India
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Biocon has said it plans to launch the world's first biosimilar version of Roche's breast cancer blockbuster Herceptin in India next month.

The biosimilar - called CANMAb (trastuzumab) - was jointly developed by Biocon and generics giant Mylan and has been approved for the treatment of HER2-positive metastatic breast cancer, a form of the diseases which accounts for around a quarter of the 150,000 new cases of breast cancer diagnosed in India every year.

Biocon said that while Herceptin has been available in India for years, a "lack of affordable treatment options has limited the extent of HER2 testing and it is believed that the proportion of HER2-positive patients is probably higher".

Roche was awarded an Indian patent on Herceptin in 2007 that extends to 2019, but last year decided to relinquish its protection in order to allow other companies to introduce lower-cost versions.

It has been suggested the company took the decision after it emerged it was facing compulsory licensing for Herceptin in India on the grounds of public need, a path which opened the door to generic competition to Bayer's cancer drug Nexavar last year.

Biocon estimates that the Indian market for Herceptin is tiny, accounting for only around $21m out of global turnover of $6.4bn in 2012.

Launch supplies of CANMAb are being manufactured at Biocon's biologics facility in Bangalore and the biosimilar will be available to patients around the first week of February 2014, according to the Indian company.

The new version of trastuzumab will be priced at around a 25 per cent discount to Herceptin, and the company is also making a low-dose (150mg) vial available at a cost of 19,500 rupees that "will allow extra savings to patients as they can buy smaller quantities as per their requirement."

Roche is also developing a biosimilar trastuzumab for the Indian market as part of a collaboration with Emcure Pharmaceuticals set up in 2012.

Article by
Phil Taylor

20th January 2014

From: Sales



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