BioPharmaSpec provides a complete solution for Evolocumab/ Repatha comparability, biosimilarity and characterization studies.

Evolocumab (Trade name: Repatha┬«) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 ia a protein that targets LDL receptors for degradation, thereby reducing the liver’s ability to remove LDL-C from the blood. Repatha┬« is used to treat hyperlipidemia.

Biosimilar Characterization Considerations

The guidelines state that Evolocumab/ Repatha comparability and characterization should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:

Structural Characterization

Physicochemical Characterization

Functional Testing by Custom Biologics

  • Binding Assays
  • Receptor Binding Assays

Product Specific Technical Considerations

Particular attention should be paid to the Post Translational Modifications (PTMs) including:

  1. Levels of Pyroglutamination
  2. Disulfide bridges and analysis of the various disulfide bridged isoforms
  3. Heavy chain C-terminal Lysine
  4. Glycosylation (in particular, levels of galactosylation and fucosylation)
  5. Deamidation
  6. Oxidation