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Study Scope and Reference Product

Study objective clearly states comparability or biosimilarity intent critical (required)

The protocol or report explicitly states whether the study is intended to support comparability, biosimilarity, or both.

Yes No N/A

Reference product is clearly identified and justified critical (required)

The reference product, lot selection rationale, and source are documented and traceable.

Yes No N/A

Product and process comparability boundaries are defined

The scope includes the specific product attributes, process changes, or development stages being compared.

Yes No N/A

Acceptance criteria are defined for the study conclusion critical (required)

Predefined decision criteria exist for determining whether similarity or comparability is demonstrated.

Yes No N/A

Study rationale aligns with ICH Q5E principles

The approach reflects a risk-based comparability assessment and does not rely on unsupported assumptions.

Yes No N/A

Analytical and Biological Assay Panel

Assay panel covers critical quality attributes critical (required)

The analytical package includes assays for identity, purity, potency, glycosylation or other relevant structural attributes, as applicable.

Biological activity assay is qualified and relevant critical (required)

A biological assay relevant to mechanism of action or functional activity is included and appropriately qualified.

Yes No N/A

Assays are fit for purpose and method status is documented

Each assay has a documented status such as qualified, validated, or exploratory, with rationale for its use in the similarity assessment.

Assay sensitivity and specificity are addressed

The study documents whether the methods can detect meaningful differences between test and reference product.

Yes No N/A

Replicate strategy and sample panel are defined

The number of lots, replicates, and sample selection strategy are specified for both test and reference materials.

Yes No N/A

Assay reference documents are linked

SOPs, method summaries, or validation reports supporting the assay panel are available and linked.

Yes No N/A

Statistical Design and Data Analysis

Statistical analysis plan is documented before data review critical (required)

The analysis plan is defined in advance and includes the methods used to compare test and reference results.

Yes No N/A

Similarity metrics and equivalence approach are defined critical (required)

The study specifies the statistical framework used, such as equivalence testing, confidence intervals, or multivariate similarity methods.

Acceptance margins are scientifically justified critical (required)

Similarity margins or equivalence bounds are justified based on prior knowledge, assay variability, and product risk.

Yes No N/A

Sample size and power assumptions are documented

The analysis includes the rationale for lot count, replicate count, and statistical power where applicable.

Yes No N/A

Outlier handling and missing data rules are defined

The protocol states how outliers, missing values, and failed runs are handled in the analysis.

Yes No N/A

Data visualization supports the similarity conclusion

Plots, trend charts, or multivariate outputs are included to show the relationship between test and reference product results.

Yes No N/A

Documentation, Traceability, and Conclusion

Raw data, calculations, and data lineage are traceable critical (required)

Source data, calculations, and transformations can be traced from the final report back to the original records.

Yes No N/A

Deviations and protocol exceptions are documented

Any deviations from the approved protocol are recorded, assessed, and dispositioned.

Yes No N/A

Conclusion is supported by the data package critical (required)

The final conclusion is consistent with the analytical and biological data and does not overstate similarity.

Yes No N/A

Regulatory and quality review sign-off is complete critical (required)

Appropriate CMC, quality, and regulatory stakeholders have reviewed and approved the package.

Open issues and follow-up actions are captured

Any deficiencies, non-conformances, or required follow-up actions are listed with owners and due dates.

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Run: Comparability and Biosimilarity Analytical Similarity Study Inspection

Study Scope and Reference Product

Analytical and Biological Assay Panel

Statistical Design and Data Analysis

Documentation, Traceability, and Conclusion

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