Court order rules in favour of Roche, prevents Reliance to launch Herceptin Biosimilar in India

The Delhi High Court has blocked Reliance Life Sciences from launching a copy of Swiss pharma company Roche’s breast cancer drug trastuzumab.

In its November 2 order, the court directed both parties to file written submissions by November 16, following which it will hear the case on a day-to-day basis and not permit adjournments.

Roche has argued that Reliance has not conducted certain tests that prove its product is similar to Roche’s drug, which sells under the brandname Herceptin. Roche has said that if the product is not taken through all the stages of tests before being developed into the final product it could raise quality issues. 

Biocon and Mylan have their respective copies of Herceptin in the Indian market.

Reliance Life Sciences has reportedly recently obtained package insert approval for its biosimilar version named TrastuRel.

Zydus Cadila is also on process in launch the biosimilar version of the drug in Indian market. Biotechnology major Biocon is selling breast cancer drug ‘CANMAb‘, developed jointly with US-based Mylan