SB3, a biosimilar of trastuzumab currently approved in the EU, Korea, Australia, the USA, and Brazil, was characterized in vitro for the purpose of supporting bioequivalence with trastuzumab in terms of its molecular mechanism of action (MoA). |
SB3 demonstrated high similarity to the reference product with regards to quality attributes related to extracellular and intracellular mechanisms of action. |
Combination studies with docetaxel and pertuzumab confirmed molecular MoA similarity between SB3 and the reference product. |