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Biocon has lashed out at Roche a day after the Swiss company secured an order from the Delhi High Court barring the Indian company from marketing its new drug, co-developed with Mylan, as a biosimilar of Roche’s blockbuster Herceptin, used for the treatment of HER-2 positive breast cancer.
“It is extremely shocking, but not unexpected. This proceeding is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more-affordable Trastuzumab,” Biocon said.
Canmab, to be sold by Biocon, and Hertraz, to be sold by Mylan, were launched in India earlier this year as biosimilars to Roche’s Trastuzumab, Herceptin, and positioned as more affordable options and targeted at emerging markets.
In anticipation of the launch of drugs, Roche had even slashed the price 50 per cent in India. The products of Biocon and Mylan are priced at a 25-30 per cent discount to Herceptin’s price.
On Friday, Roche claimed it had filed the case against Biocon, US-based Mylan and the Drugs Controller General of India (DCGI) as it was its duty to ascertain if the drugs were indeed similar to its own innovation.
Roche has alleged the Clinical Trials Registry in India did not have any publicly-available data on the Phase-I and Phase-II clinical trials by the companies, a mandatory requirement while developing the drug.
“There is very limited information in the public domain and we believe it is important to ensure patients and physicians can make informed decisions. More, as far as we are aware, the Indian regulatory authorities have approved Biocon and Mylan’s products as Trastuzumab, by their regulatory process, but it is unclear if the products meet the criteria for biosimilar products,” according to a spokesperson