Addressing uncertainty in biosimilarity Posted 07/09/2018

How to address uncertainty in biosimilarity was a subject discussed by Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA) during the Drug Information Association’s Biosimilars Conference 2017 [1].
In its guidance on pharmacology data for biosimilarity, the FDA states that clinical pharmacology data is ‘a critical part of demonstrating biosimilarity’ and outlines three key concepts that the agency believes are ‘especially relevant to the stepwise development of proposed biosimilar products’ [2]: When assessing uncertainty Dr Lynch points to the following as important considerations: – Do orthogonal methods corroborate an impact on function?
– Refine manufacturing control strategy to ensure lots meet acceptable limits? In its guidance on Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product [3], FDA highlights the importance of functional assays in the assessment of uncertainty by stating that ‘functional assays are also critical tools for evaluating the integrity of the higher order structures’. In particular Dr Lynch points to the following:
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– Is the difference clinically meaningful?
Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA), stated that his presentation reflects the views of the author and should not be construed to represent FDA’s views or policies.
Lot selection and handling for biosimilarity
1. Lynch P. Expectations and approaches for demonstrating analytical similarity. DIA Biosimilars Conference; 24–25 October 2017; Bethesda, Maryland, USA.
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on pharmacology data for biosimilarity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-pharmacology-data-for-biosimilarity
3. GaBI Online - Generics and Biosimilars Initiative. FDA finalizes biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from: www.gabionline.net/Guidelines/FDA-finalizes-biosimilars-guidelines
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