The results of a phase I study published in Annals of Medicine is said to have established biosimilarity between Beijing SL Pharmaceuticals’ pertuzumab biosimilar, KM118, and the reference product, Roche’s Perjeta®.
Roche has previously claimed it is unconcerned about biosimilar pertuzumab products despite pertuzumab biosimilars being considered for approval in China, Europe and the USA (all by Henlius), and approved in India (Zydus and Intas) and Russia (Biocad).