ZURICH Pharmaceutical group Roche said it secured an injunction from an Indian court banning generic drug makers Biocon and Mylan from comparing their copycat versions of Roche's Herceptin breast cancer treatment to the original.
Mylan and Biocon, which co-developed breast cancer drugs CANMab and Hertraz they say are biosimilars of Herceptin, are no longer allowed to refer to Herceptin or its manufacturing process, safety, efficacy and sales when communicating about their drugs, the New Delhi High Court ruled on Wednesday.
India's Biocon and U.S.-based Mylan launched CANMab and Hertraz in India this year after Roche decided last summer not to pursue a patent application for Herceptin in India, paving the way for generic drugmakers to produce cheaper copies, known as biosimilars because they are not identical to the original drug.
"Roche has filed and secured an injunction against Biocon and Mylan. The injunction prevents the companies from comparing their products to Herceptin," Roche spokeswoman Silvia Dobry said in an emailed statement on Friday.
She said Roche had taken this action to make sure Biocon and Mylan's products really had demonstrated comparable efficacy and safety to Roche's drug.
"It is unclear if the products meet the criteria for biosimilar products," she said.
Biocon and Mylan won approval from the Indian drug regulator in November for marketing a generic version of Herceptin.
Biocon said in a statement on its website the injunction was "an extremely shocking, but not unexpected development", adding Roche was trying to prevent Indian patients from accessing a more affordable trastuzumab, the generic name of Herceptin.
"We are confident that once we are heard by the court, this injunction placing certain limits on promotional activities will not stand," Biocon said.
Mylan could not immediately be reached for comment.
Western pharmaceutical companies are keen to tap into India's $13 billion drug market, but there are concerns about the level of protection for intellectual property in the country, where generic medicines account for more than 90 percent of drug sales.
(Reporting by Silke Koltrowitz; Editing by Elaine Hardcastle)