Comparative safety assessments of the biosimilar APZ001 and Erbitux in pre-clinical animal models

Subject of this validation was the quantitative determination of Tysabri ® (Natalizumab) in serum samples. This assay employed the quantitative antibody sandwich enzyme immunoassay technique (ELISA). A microtiter plate was coated with a specific anti-Natalizumab antibody.After blocking, calibration samples, quality control samples (QCs) or study samples were pipetted into the wells. After washing, the HRP-conjugated secondary anti-Natalizumab antibody

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Comparative safety assessments of the biosimilar APZ001 and Erbitux in pre-clinical animal models

Abstract: The safety comparisons between APZ001 antibody and Erbitux showed that these two antibodies showed highly similarities in mice, rabbits and cynomolgus monkey animal models in consideration of pharmaceutical effects, indicating APZ001 might be a suitable substitute for Erbitux.

Cited by 2 publications

References 16 publications

Why is there no biosimilar of Erbitux®?

Why is there no biosimilar of Erbitux®?

4-Week toxicity study of biosimilar natalizumab in comparison to Tysabri^® by repeated intravenous infusion to cynomolgus monkeys

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Comparative safety assessments of the biosimilar APZ001 and Erbitux in pre-clinical animal models

Abstract: The safety comparisons between APZ001 antibody and Erbitux showed that these two antibodies showed highly similarities in mice, rabbits and cynomolgus monkey animal models in consideration of pharmaceutical effects, indicating APZ001 might be a suitable substitute for Erbitux.

Cited by 2 publications

References 16 publications

Why is there no biosimilar of Erbitux®?

Why is there no biosimilar of Erbitux®?

4-Week toxicity study of biosimilar natalizumab in comparison to Tysabri® by repeated intravenous infusion to cynomolgus monkeys

Contact Info

Product

Resources

About

4-Week toxicity study of biosimilar natalizumab in comparison to Tysabri^® by repeated intravenous infusion to cynomolgus monkeys