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PIL against Indian stroke drug motivated: Gennova to HC

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The pharma firm’s response came on a plea by Deep Das, who has sought to know how the biosimilar drug could be approved when the innovator drug made by Boehringer has not been approved

An Indian pharma company Gennova Biopharmaceuticals has claimed in Delhi High Court that the plea seeking to stop them from launching a drug to treat stroke patients was “motivated and not maintainable”.

The submission was made before a bench of Chief Justice G Rohini and Justice Sangita Dhingra Sehgal, who were hearing a plea which has questioned the approval given to Gennova with regard to its biosimilar drug of Tenecteplase which is used for treating stroke patients.

The Indian pharma company in its affidavit has alleged that the plea for restraining them has been filed by the petitioner “at the behest of” German pharma major Boehringer Ingelheim, which is a competitor having “vested commercial interests” in preventing them from launching ‘Tenectase’.

“Boehringer is on record advising doctors in the medical fraternity not to prescribe Gennova’s product for stroke as their product is not approved for this indication,” Gennova alleged, adding that “the plea is motivated and not maintainable. It is a private interest filed under the guise of PIL”.

It said it was already marketing a Tenecteplase (TNK-t- PA) drug under the brand name Elaxim.

The pharma firm’s response came on a plea by Deep Das, who has sought to know how the biosimilar drug could be approved when the innovator drug made by Boehringer has not been approved.

He sought revocation of the recommendations in favour of the biosimilar drug and the marketing approval granted to it.

The plea also seeks directions restraining the company from launching the medicine and if launched, a declaration ot the effect that it was done illegally.

According to the petition, the DCGI had allowed Gennova to carry out clinical trials of the medicine in February 2009 and December 2013.

Source: PTI

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