Roche plea in high court on cancer drug not maintainable: Mylan, Biocon

(Ref: Times of India)
  • Biocon and Mylan argued before the Delhi High Court that Roche's lawsuit seeking to block the launch of biosimilar version of the cancer drug Herceptin was not maintainable, as reported The Times of India Wednesday.

  • In its litigation, Roche contends that the Drugs Controller General of India (DCGI) granted approval to the drugmakers even though they not conduct all required tests.

  • Biocon and Mylan noted that restrictions were placed on the approvals of their drugs, marketed under the names CANMab and Hertraz, respectively.

  • DGCI standing counsel Amit Mahajan Amit Mahajan claimed that the "approvals were validly granted."

  • Meanwhile, Mylan lawyer Amit Sibal stated that approvals granted by the regulator cannot be challenged by a civil suit.

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