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Roche blocks Herceptin biosimilar in India

Wins court battle after claiming Biocon and Mylan had not followed regulatory criteria
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Roche has won a last-minute reprieve from biosimilar competition to its breast cancer drug Herceptin in India.

The Swiss pharma major convinced the High Court in Delhi that the data filed in support of the marketing application for Biocon's CANMAb and Mylan's Hertraz (trastuzumab) biosimilar brands may be flawed, rendering their approvals invalid.

Herceptin has been an intellectual property (IP) battleground in India, with threats of compulsory licensing eventually causing Roche to relinquish its patents on the drug in India, clearing the path for lower-cost competition.

Roche argued in the High Court that Biocon and Mylan had not shown that their products were equivalent to Herceptin using criteria laid down in the India's Guidelines on Similar Biologics, which were published in October 2012, and so should not be able to market their products as biosimilar to the original brand.

Specifically, its counsel said that the defendants could not have secured approval via the due process in such a short period of time, so Biocon and Mylan must have filed before the guidelines - and the criteria for equivalency - were published.

The complex nature of biologics means that unlike their small-molecule chemical cousins it is practically impossible to duplicate a drug entirely, as even a single manufacturer's product will exhibit variations between production runs.

Presiding judge Manmohan Singh concurred with Roche's viewpoint, and indicated that Biocon and Mylan should not be able to market their drug by referring to Herceptin until the "requisite approvals" had been granted.

That effectively means that Biocon and Mylan are not blocked from manufacturing their trastuzumab products, but will be unable to market them. The two companies had indicated they would launch their biosimilars this month at a 25 per cent discount to Roche's drug.

In a statement, Roche said it was "seeking to clarify if Biocon and Mylan's products have demonstrated comparable efficacy and safety to our innovator product trastuzumab." A hearing in the case is expected on February 28.

Biocon has estimated that the high price for Roche's drug has meant that the Indian market for trastuzumab is currently tiny, accounting for only around $21m of global turnover of $6.4bn for Herceptin in 2012.

Article by
Phil Taylor

10th February 2014

From: Sales, Regulatory

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