The research-grade biosimilar is a human IgG2 monoclonal antibody that is directed against proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a serine protease that binds to LDL receptors on the hepatocyte cell surface and promotes the lysosome-mediated degradation of these receptors. This results in decreased uptake and clearance of LDL-C (bad cholesterol) by the receptors. The monoclonal antibody binds to PCSK9 and prevents interaction with the LDL receptor. This promotes the recycling of the internalised LDL receptor to the hepatocyte cell surface and increased removal of LDL-C from the blood. The original drug received approval from the FDA to treat homozygous and heterozygous familial cholesterolemia. The drug has also been approved to treat patients with high cholesterol, whose LDL-C was not controlled by the statin treatment.
In PBS, pH 7.5