Analytical consideration in demonstrating similarity for biosimilars

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According to the US Food and Drug Administration (FDA) guideline on ‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product’ [1], ‘FDA expects that first, a sponsor will extensively characterize the proposed product and the reference product with state‐of‐the‐art technology, because extensive characterization of both products serves as the foundation for a demonstration of biosimilarity’ [2].

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The guidelines also specify that biosimilar applicants should demonstrate biosimilarity using a stepwise approach, which includes structural and functional characterization, animal toxicity, pharmacokinetics and pharmacodynamics, immunogenicity, and clinical safety and effectiveness [2].

The stepwise approach starts with extensive structural and functional characterization. This allows for an evaluation of the analytical differences and resulting residual uncertainty about biosimilarity. The next steps to try to address that uncertainty can then be identified. Orthogonal methods can then be used to further evaluate the impact on function. Control strategies should then be used to minimize differences. Finally, non-clinical and clinical evaluation of the biosimilarity should be carried out.

In a presentation on Expectations and Approaches for Demonstrating Analytical Similarity at the US Drug Information Association’s Biosimilars Conference [3], Dr Lynch highlighted that demonstrating analytical similarity is the foundation to demonstrating biosimilarity. Analytical considerations that need to be taken into account are given in Figure 1.

Figure 1: Analytical considerations for biosimilarity

GW 3329G Fig 1

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.

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1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 26]. Available from:
2. U.S. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. April 2015 [homepage on the Internet]. [cited 2018 Jul 13]. Available from:
3. Lynch P. Expectations and approaches for demonstrating analytical similarity. DIA Biosimilars Conference; 24-25 October 2017; Bethesda, Maryland, USA.

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