Biologics

FDA Posts 2 Biosimilar Development Guides

FDA has issued two final guidances related to biosimilar development. The final guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations provides recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product. Additionally, it is intended to provide recommendations to sponsors on the scientific and technical information for chemistry, manufacturing, and controls.

FDA recommendations, according to the guidance, on biosimilar product characterization include:

Comprehensive characterization is essential: A thorough understanding of the physicochemical and biological properties of the proposed biosimilar is critical for process design, development studies, and ultimately for demonstrating product quality and obtaining approval.
Comparative analyses required: Sponsors should conduct in-depth comparative studies of multiple lots of both the biosimilar and the reference product. This helps assess variability across lots. The number of lots should be scientifically justified and discussed with FDA.
Acceptance criteria should be risk-based: Criteria should reflect the totality of analytical data and patient impact, not just the observed attribute ranges in the reference product. Interactions among attributes (e.g., glycosylation patterns) must be considered.
Use of advanced analytical methods: Orthogonal and quantitative techniques should be developed to identify and assess differences in attributes such as higher-order structure, posttranslational modifications, impurities, and degradation.
Targeted clinical studies: Analytical data can serve as the scientific basis for a selective, risk-based approach to clinical studies needed to demonstrate biosimilarity.
Comparative algorithms may be useful: Structured analytical approaches (e.g., meaningful algorithms covering many quality attributes) can help interpret differences between biosimilar and reference products.

The other final guidance, Classification Categories for Certain Supplements Under BsUFA III, provides recommendations for biosimilar manufacturers as well as FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications. It is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.

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