Bioanalytical challenges of biosimilars

Area of Science:

• Pharmaceutical Science
• Biotechnology
• Analytical Chemistry

Background:

• Biologics, including monoclonal antibodies and recombinant proteins, are key pharmaceutical products.
• Expiring patents on first-generation biologics are driving an increase in biosimilar development.
• Regulatory pathways for biosimilar approval exist, but specific bioanalytical testing guidance is lacking.

Purpose of the Study:

• To address the specific bioanalytical challenges in biosimilar drug development.
• To provide insights into solutions for analyzing biosimilars in biological samples.
• To focus on critical components of pharmacokinetic (PK) and immunogenicity assays for biosimilars.

Main Methods:

• Review of existing regulatory guidances and white papers on biologics testing.
• Identification of critical assay components for PK analysis of biosimilars.
• Identification of critical assay components for immunogenicity analysis of biosimilars.

Main Results:

• Lack of established bioanalytical testing guidance specific to biosimilars.
• Identification of key PK assay parameters crucial for biosimilar characterization.
• Identification of key immunogenicity assay parameters essential for biosimilar safety assessment.

Conclusions:

• Standardized bioanalytical methods are needed for biosimilar evaluation.
• Addressing PK and immunogenicity assay challenges is vital for successful biosimilar development and approval.
• This work highlights areas for future guidance development in biosimilar bioanalysis.