On 27 November 2025, India’s Medical Dialogues reported that Intas Pharmaceuticals has received approval in India to conduct a phase I trial comparing its INTP78 combination of pertuzumab and trastuzumab with the reference product, Roche’s Phesgo®. Intas already has approval to market its biosimilar pertuzumab in India and, through its subsidiary Accord BioPharma, biosimilar trastuzumab in the USA.
There has been significant activity in relation to biosimilars to pertuzumab and trastuzumab as separate treatments. Amgen has previously conducted trials on the combination.
Roche has recently indicated that biosimilar competition to Perjeta® (pertuzumab) 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.