ADJ-415 meets primary endpoint in phase III equivalence study

The trastuzumab biosimilar programme reports comparable efficacy and safety to the reference product.

The phase III equivalence study of ADJ-415, a proposed trastuzumab biosimilar, met its primary endpoint, with response rates within the pre-specified equivalence margin against the reference product.

Secondary endpoints, including progression-free survival and adverse-event profile, were consistent with the reference across the study population of approximately 640 patients.

A biosimilar is only as good as the analytics that prove it.

Comparability was established analytically before the clinical programme began: higher-order structure, glycan profile and impurity fate were characterised and locked ahead of process validation.

The dossier is being prepared for submission across three markets under the accelerated pathway.