Module 9 2024

03/09/2024

Assay Controls

Immune response in patients • Individual, polyclonal response • varying over time in a patient; varying between patients (transient versus persistent Abs, affinity maturation, titer, affinity) → ideal positive control Ab: derived from treated patients who develop an immune response - not available Positive controls (important for assay development and validation e.g., determination of assay sensitivity and specificity, assessment of drug tolerance) = surrogate for the immune response that may occur in humans • affinity purified polyclonal sera from hyperimmunised animals

• recombinant monoclonal antibodies, spiked into appropriate matrix

Negative controls (important for cut-point determination) • normal human sera (pooled) • pre-therapy sera from patients • irrelevant antibody

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Biosimilars

A biosimilar should not demonstrate any clinically meaningful difference compared to its reference product in terms of quality, safety and efficacy.

Comparative immunogenicity assessment is an essential element for demonstration of biosimilarity – aiming to evaluate potential differences in immunogenicity profiles.

Clinical program must include at least one study for comparison of immunogenicity of proposed biosimilar versus reference product.

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