On 28 June 2024, Zydus and Dr Reddy’s announced that they have entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India. Dr Reddy’s receives semi-exclusive rights under the agreement, while Zydus will receive upfront and subsequent milestone payments. Zydus will market its pertuzumab biosimilar to Roche’s Perjeta® under the trade name Sigrima™, with Dr Reddy’s supplying Womab®.
This comes after Medical Dialogues published on 27 June 2024 that New Delhi’s Subject Expert Committee functional under the Central Drug Standard Control Organisation (CDSCO), approved Zydus Life Sciences’ pertuzumab biosimilar for the additional indication of early breast cancer. CDSCO’s approval is conditional on Zydus conducting a Phase IV study of the drug for the new indication.
Earlier this month, results of a study sponsored by Qilu Pharmaceuticals were published demonstrating comparable efficacy and safety of Qilu’s QL1209 to Perjeta® (pertuzumab) in neoadjuvant treatment of HER2-positive, ER/PR-negative, early or locally advanced breast cancer.