Bring your drug to market swiftly with a risk-based, multivariate approach that fully supports the biosimilarity demonstration.
Benefits this Solution Provides
Accelerate Time to Market
Less time-consuming analysis allows for easier detection of similarities and differences.
Expedite Regulatory Approval
Use robust reporting tools to support regulatory submissions.
Fully Align with the Totality-of-Evidence Framework
Generate adequate clinical evidence of biosimilarity demonstration.
Assure Quality, Safety, and Efficacy of the Final Product
Use a risk-based approach to understand the impact of each quality attribute on clinical outcomes.
Optimize for Totality-of-Evidence
- Ensure biosimilar approval following a totality-of-evidence approach, as defined by the FDA.
- Justify regulatory approval based on the sum of analytical, non-analytical, and clinical studies.
- Collect different data types for multiple quality attributes derived from different analytical techniques.
Fingerprint-Like Similarity and Residual Risks
- Improve your assessment using a multiparametric and multivariate approach to compare biosimilar domains and reference products for easier detection of similarities and differences and less time-consuming analysis.
- Implement a stepwise, risk-based approach that binds together the impact and uncertainty of each quality attribute in clinical outcomes.
Improve Your Similarity Assessments
- Clearly visualize critical quality attributes (CQAs).
- Assess high levels of similarity between quality attributes.
- Generate evidence of clinically meaningful differences between the product and its approved reference.
- Use a range of reporting tools to support regulatory submissions.
What Can You Expect From Implementing Our Solution?
|Perform comparability assessments using classical statistical approaches.||Perform comparability assessments using multiparametric and multivariate approaches.|
|Perform blinded univariate verification analysis of variables one by one.||Focus univariate verification analysis on the variables with major differences (guided analysis).|
|Perform quality criticality assessment with subjectivity.||Use risk tools to see the impact of each variable on a product’s CQAs.|
|Generate unnecessary evidence.||Generate adequate evidence to support regulatory submissions.|
|Before||Perform comparability assessments using classical statistical approaches.|
|After||Perform comparability assessments using multiparametric and multivariate approaches.|
|Before||Perform blinded univariate verification analysis of variables one by one.|
|After||Focus univariate verification analysis on the variables with major differences (guided analysis).|
|Before||Perform quality criticality assessment with subjectivity.|
|After||Use risk tools to see the impact of each variable on a product’s CQAs.|
|Before||Generate unnecessary evidence.|
|After||Generate adequate evidence to support regulatory submissions.|
See how ValGenesis can support your digital transformation.