On 16 October 2024, the Economic Times reported that the Delhi High Court has reinstated an injunction preventing Zydus from manufacturing, selling or marketing Sigrima™, biosimilar to Roche’s Perjeta® (pertuzumab).
The 16 October 2024 decision of the Delhi High Court follows an appeal by Roche of an earlier order of the Court on 9 October 2024, which reversed an injunction order originally granted in July 2024.
The injunction was ordered in proceedings commenced by Roche earlier this year, in which Roche alleges that Zydus’ Sigrima™ infringes Indian patent numbers IN 268632 and IN 464646. 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 Sigrima™ (Zydus) and Womab® (Dr Reddy’s).