What are biosimilars?

Biosimilars are approved through an accelerated process to demonstrate that there are no clinically meaningful differences from the reference product in terms of safety, purity, potency, and effectiveness.4


Originator pathway (351[a])5,6


Biosimilar pathway (351[k])5,6


OGIVRI® was demonstrated to be highly similar to reference trastuzumab in a battery of biochemical, biophysical, and functional assays and pharmacokinetics analyses7,8

Over 35 sensitive, state-of-the-art methods were employed to demonstrate high similarity between OGIVRI & reference trastuzumab at physico-chemical & biological level.7

In a single-center, randomized, double-blind, phase 1 study of single IV infusion in 132 healthy adult male volunteers randomized 1:1:1 to receive OGIVRI, EU - trastuzumab, or US - trastuzumab.7

  • OGIVRI had a similar pharmacokinetic profile to trastuzumab, both EU and US sourced
  • No differences between treatments were observed in adverse events or in occurrence of antidrug antibodies