On 12 November 2025, Sandoz and EirGenix announced a global licensing agreement for the commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab). Under the agreement, Sandoz will have exclusive worldwide commercial rights to the biosimilar, excluding certain countries in Asia, while EirGenix will be responsible for development, manufacturing and supply.
EG1206A has completed its pharmacokinetic clinical study and last month received positive feedback from both the FDA and the European Medicines Agency, confirming that the product qualifies for an abbreviated development pathway allowing for the waiver of Phase III comparative efficacy trials.
Sandoz and EirGenix previously signed a global commercialisation agreement for EG12014, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab), which was approved by the European Commission in November 2023 and is currently under review by the FDA.
Roche has recently indicated that biosimilar competition to Perjeta® is a bigger concern than it previously anticipated. Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.