At a meeting on 5 December 2024, the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) approved Zydus’ Sigrima®, biosimilar to Roche’s Perjeta® (pertuzumab), in patients with HER2-positive metastatic and early breast cancer.
This approval has been given while there are ongoing court proceedings relating to an injunction ordered in proceedings commenced by Roche earlier this year, in which Roche alleged that Zydus’ Sigrima™ infringes Indian patent numbers IN 268632 and IN 464646. As reported last month, the injunction is currently being considered by the Delihi High Court.