In a major turn of events, the Indian arm of Swiss pharma major Roche, recently sued Bangalore based Biocon and US based generic giant Mylan in Delhi High Court (HC) for launching world’s first biosimilar version of its original breast cancer drug Herceptin (trastuzumab) in India. It is understood that the company has also sued the Drug Controller General of India (DCGI) for giving permission for such a launch. Roche has told the court that the drugs of Biocon and Mylan are being misrepresented as ‘biosimilar Trastuzumab’ and ‘biosimilar version of Herceptin’ without following the ‘due process in accordance with the guidelines on similar biologics’ for getting approvals in India.
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