Retrospective Analysis of Bioanalytical Method Validation Approaches in Biosimilar Biological Product Development.

Area of Science:

• Biopharmaceutical analysis
• Drug development science
• Analytical chemistry

Background:

• Bioanalytical method development and validation are critical yet challenging for biosimilar biological product development (BPD).
• Accurate measurement of both biosimilar and reference products in biological matrices is essential.
• Current bioanalytical practices in BPD require comprehensive review.

Purpose of the Study:

• To summarize the bioanalytical landscape in biosimilar biological product development (BPD).
• To review bioanalytical method validation approaches used in BPD.
• To analyze bioanalytical bias differences between biosimilar and reference products.

Main Methods:

• Analysis of bioanalytical data from 28 biosimilar biologic license applications submitted to the U.S. Food and Drug Administration (FDA) up to December 2018.
• Review of bioanalytical method validation strategies.
• Assessment of bioanalytical bias data.

Main Results:

• Significant diversity observed in bioanalytical approaches employed for BPD.
• Variability noted in bioanalytical method validation strategies.
• Differences in bioanalytical bias between proposed biosimilar and reference products were identified.

Conclusions:

• Understanding critical aspects of BPD bioanalysis is crucial.
• Clarifying best practices for bioanalytical method validation in BPD is needed.
• Standardized approaches can enhance consistency in the BPD community.