In a landmark injunction granted on 9 July 2024, the Delhi High Court has temporarily banned Zydus Lifesciences from selling its breast cancer drug SigrimaTM, biosimilar to Roche’s Perjeta® (pertuzumab). The injunction was ordered in proceedings commenced by Roche earlier this year, in which Roche alleges that Zydus’ SigrimaTM and Dr Reddy’s co-marketed Womab® infringe Indian patent numbers IN 268632 and IN 464646.
The injunction is to remain in place until the next hearing date on 18 July 2024.
According to the Court order, Zydus received conditional approval for its pertuzumab biosimilar from the Central Drug Standard Control Organisation (CDSCO) on 4 April 2024, obtained permission to market the drug on 27 June 2024 and subsequently launched Sigrima™ on the Indian market.
On 28 June 2024, Zydus and Dr Reddy’s announced that they had entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India as SigrimaTM (Zydus) and Womab® (Dr Reddy’s).