In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act, the agency published draft guidance on biosimilar interchangeability in January 2017 [2].

Dr Lynch made the following recommendations about demonstrating analytical similarity for biosimilars:

• A well‐planned and comprehensive analytical programme allows for evaluation of analytical similarity based on a totality‐of‐the evidence approach
• Failure to meet predefined acceptance criteria on a statistical test does not necessarily preclude determination of ‘highly similar’
• A robust analytical similarity programme that includes in‐depth structural and functional characterization improves the likelihood that any analytical differences between highly similar products can be addressed
• Plan ahead to ensure sufficient numbers of independent lots are available for statistically rigorous evaluation

His presentation covered expectations for analytical similarity studies, including analytical considerations, ranking and evaluation of quality attributes and lot selection/handling, as well as how to address uncertainty, which included discussion of structure–function relationships and example case studies.

These subjects are covered in more detail in the following series of four articles.

Disclaimer
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.

Related articles
Addressing uncertainty in biosimilarity

Lot selection and handling for biosimilarity

Ranking and evaluation of quality attributes for biosimilarity

Analytical consideration in demonstrating similarity for biosimilars

References
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 FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilar-interchangeability

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