They are structurally and functionally similar to therapeutic antibodies approved by the FDA. The available biosimilar antibodies are solely for research use and are engineered with recombinant antibody technology using the same sequence as the originator therapeutic (reference) antibody.
How are biosimilar antibodies produced?
- Biosimilar antibodies are made using recombinant antibody technology
- They are derived from genetically modified cells
- They are produced from alternate clones and production processes than the original antibody
What are biosimilar antibodies utilized for?
- Research: Assay development, blocking/neutralizing, and immunocytochemistry
- Therapeutic research: To investigate potential therapeutic interventions for diseases
- Bridging assays: To capture and detect anti-drug antibodies in patient samples
- Pharmacokinetic (PK) assays: Employed for studying the drug's absorption, distribution, metabolism, and excretion
What are the biosimilar antibodies like?
- They are validiated for binding to the same molecule that the reference antibody binds to
- They are assessed for endotoxin level, purity, and protein aggregation
- They are preservative-free, carrier protein-free, and stabilizer-free
