Roche wins battle against India sales of generic cancer drug

Two generic pharmaceutical companies have been ordered to stop selling their version of a Roche breast cancer treatment in India, after the Swiss group claimed that the drugmakers could not have carried out adequate clinical trials.

Bangalore-based Biocon was expected to start selling a biosimilar version of Roche's blockbuster biologic drug Herceptin - which earned $6.4bn in global revenues for the Swiss company in 2012 - in India this month for about a quarter of the price of the original.

However, the Delhi High Court issued an injunction that Biocon and US-based Mylan, which jointly developed the generic medicine, were "not entitled to introduce or launch the drug" until they had persuaded the court that their product had undergone sufficient testing.

The lawsuit launched by Roche against the companies and industry regulator the Drugs Controller General of India is the latest in a series of legal battles by global pharmaceutical innovators facing stiff competition from Indian generic rivals.

The case highlights innovating companies' determination to use all available tools to defend their position in India's potentially lucrative drugs market, in spite of their persistent complaints about the country's weak intellectual property laws.

Indian patient groups, which had fought against Roche's patent for Herceptin, have expressed outrage at the court order, calling it "unwarranted and inexplicable".

Roche unexpectedly relinquished its Herceptin patent in India in August amid mounting legal challenges, and following strong indications that New Delhi was preparing to announce a compulsory licence for the cancer drug.

Within months of Roche abandoning the patent, Biocon received the Indian drug regulator's approval to start marketing its biosimilar version of Herceptin, and was due to commence selling the product this month.

At the time of the announcement in November, Biocon said it had been working with Mylan, one of the world's largest generic drugmakers by revenues, since 2009 on a range of biologic drugs - complex treatments derived from living organisms - including Trastuzumab, the scientific name for Herceptin.

Kiran Mazumdar-Shaw, chief executive of Biocon, said that the two companies had jointly carried out "extensive product characterisation and clinical trials the comparability and similarity . . . in safety and efficacy . . . against the innovator product".

She also said that Biocon and Mylan would use this data to apply for permission to sell the drug in other markets, where Roche's Herceptin patent is due to expire in the next few years.

But in its lawsuit in the Delhi High Court, Roche argued that Biocon could not have followed the "due process" laid out in India's 2012 guidelines on the approval of biosimilar drugs, as "approvals could not have been granted in such a short period in view of the long procedure".

Biocon's final stage clinical trials on its version of Trastuzumab were carried out in 2012, before the Indian guidelines - which Roche was on the advisory committee for the drafting - were issued. In a statement on Friday, activists said that the guidelines were now being used "by big pharma to protect their interests", and called for a reappraisal.

An estimated 100,000 women a year in India are diagnosed with the type of breast cancer that responds to Trastuzumab. But with Herceptin priced at about $1,200 per dose, only a fraction of those women can afford it. Roche sold just $21m worth of the medicine in India in 2012.

Biocon did not respond to requests for comment.

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