Trastuzumab Biosimilar
Trastuzumab is a recombinant DNA-derived humanized monoclonal antibody that selectively binds with high affinity in a cell-based assay (Kd = 5 nM) to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein.The antibody is an IgG1 kappa that contains human framework regions with the complementarity-determining regions of a murine antibody (4D5) that binds to HER2. The humanized antibody against HER2 is produced by a
mammalian cell (Chinese hamster ovary) [CHO] suspension culture in a
nutrient medium containing the antibiotic gentamicin. Gentamicin is not
detectable in the final product. Herceptin is a sterile, white to pale
yellow, preservative-free lyophilized powder for intravenous (IV)
administration. The nominal content of each Herceptin vial is 440 mg
Trastuzumab, 9.9 mg L-histidine HCl, 6.4 mg L-histidine, 400 mg (alpha),
(alpha)-trehalose dihydrate, and 1.8 mg polysorbate 20, USP. Reconstitution
with only 20 mL of the supplied bacteriostatic water for injection (BWFI),
USP, containing 1.1% benzyl alcohol as
a preservative, yields a multi-dose solution containing 21 mg/mL
Trastuzumab, at a pH of approximately 6.