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Biosimilarity Assessments

Bring your drug to market swiftly with a risk-based, multivariate approach that fully supports the biosimilarity demonstration.

Benefits this Solution Provides

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Accelerate Time to Market

Less time-consuming analysis allows for easier detection of similarities and differences.

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Expedite Regulatory Approval

Use robust reporting tools to support regulatory submissions.

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Fully Align with the Totality-of-Evidence Framework

Generate adequate clinical evidence of biosimilarity demonstration.

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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.

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Optimize for Totality-of-Evidence

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  • 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

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  • 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. 

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Improve Your Similarity Assessments

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  • 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?

Before After
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.

Learn More From Our Experts

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Blog Post

Computer System Validation (CSV)

Leveraging Vendor Testing: A Smarter Approach to Validation

Read the Blog Post

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Industry Insight

Fast-Tracking Biosimilars Approval: How to Reduce Time-to-Market

Read the Article

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Webinar

Vendor Testing in VLMS: The Value of PDF Execution

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