On 22 July 2026, the Economic Times reported that Intas Pharmaceuticals has received marketing approval from India’s Central Drug Standard Control Organisation (CDSCO) for its trastuzumab emtansine biosimilar, referencing Roche’s Kadcyla®. No launch plans have been announced to date.
The biosimilar is approved for the same indications as the reference medicine and will be available in 100mg and 160mg single-dose vials for intravenous administration.
The approval was granted based on positive Phase III clinical trial results, which demonstrated the pharmacokinetics, efficacy, safety, and immunogenicity of the biosimilar compared to Roche’s Kadcyla®. Marketing approval was recommended by the CDSCO, subject to Intas conducting a Phase IV (post-marketing) study in India and submitting the Phase IV clinical trial protocol within three months of the grant of marketing authorisation.
The first reported Kadcyla® biosimilar was Zydus’ Ujvira®, which was launched in India in May 2021.