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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Comparative immunogenicity assessment of biosimilars

Thomas Schreitmüller1, Bettina Barton2, Artem Zharkov2

  • 1Roche Pharma Technical Operations, Regulatory Policy, F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Future Oncology (London, England)
|October 4, 2018
PubMed

The first anticancer biosimilars have entered clinical use, with many others under clinical development. Like all biologics, biosimilars may elicit unwanted immune responses that can significantly impact clinical efficacy and safety. Head-to-head immunogenicity assessment of biosimilars and their reference biologics should, therefore, be a critical component of a biosimilar's clinical development program. Various bioanalytical platforms may be used to detect and characterize immune responses, each having relative strengths and weaknesses. To fully recognize the clinical relevance of such data, regulators must be able to interpret immunogenicity results in an assay-specific context as well as in perspective of clinical pharmacology, efficacy and safety. Herein, we discuss current challenges imposed by global regulatory requirements for immunogenicity assessment of biosimilars.

Keywords:
antidrug antibodiesbiosimilaritybiosimilarsimmunoassayimmunogenicity

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