Delhi HC deferrs order blocking Gennova's Biosimilar

NEW DELHI: The Delhi High Court has deferred passing any order on a petition to stop Gennova Biopharmaceuticals from launching a biosimilar of tenecteplase, a drug used as a treatment for heart attacks but which the company wants to sell as a stroke medicine.

A biosimilar drug is a copy of a complex biotech drug. An Indian doctor had filed a public interest litigation against Pune-based Gennova and the Indian drug regulator over the process followed to give marketing approval to its tenecteplase for use in stroke patients.

Chief Justice G Rohini and Justice Sangita Dhingra Sehgal, currently hearing the case, on Wednesday decided not to pass any interim order until the Drugs Controller General of India (DCGI) and Gennova submit responses to the aggrieved party by next Monday. The next hearing in the case has been fixed for August 31.

Gennova's drug can't be approved as a biosimilar of tenecteplase as the original drug isn't prescribed for strokes, argued P Chidambaram, counsel for Deep Das, the Kolkata-based neurologist who filed the PIL.

"The comparator drug is approved world over only for myocardial infarction. It is not approved for acute ischemic stroke. How can (Gennova) then say that (its) biosimilar drug is similar to a drug which is not there in the first place?" he said.

"This (approval) is dangerous for patients," he added. Tenecteplase is marketed in India under the brand name ‘Metalyse' through a deal between German pharma giant Boehringer Ingelheim and Roche-Genentech.

Government's counsel Sanjiv Narula alleged that the drug regulator was unnecessarily being dragged into a case that was the result of a competitor's dispute, as the launch of Gennova's tenectaplase for strokes would hit Boehringer's sales of its own stroke medicine— alteplase.