Figure 3.

Schematic of the biosimilar single PK assay. Anti-idiotype antibodies were developed against the FDA-licensed reference product and used for capture and detection of the biosimilar and reference products from serum samples collected from in vivo studies. The method was established on the Meso Scale Discovery (MSD) Electrochemiluminescent (ECL) platform, and an anti-ID antibody was used to capture the biosimilar and reference product(s) from test samples, and a second ruthenium labeled anti-ID antibody was used for detection of the bound test products. In the single PK assay the biosimilar is used as the assay calibrator for quantification of both biosimilar and reference products.