Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations
Date: May 2019

The draft guidance is intended to replace draft guidance entitled ‘Statistical Approaches to Evaluate Analytical Similarity’. The agency withdrew the draft guidance in June 2018 after receiving public comments on the draft guidance that highlighted ‘a range of issues that could impact the cost and efficiency of biosimilar development’. Issues highlighted included the number of lots of reference products to be sampled [1].

The agency says that it has ‘adjusted the title of this draft guidance to more clearly communicate that this draft guidance includes the agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed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’.

The draft guidance outlines nine factors for consideration in performing comparative analytical assessments of biosimilars. These including expression systems, manufacturing process, physicochemical properties, functional activities, target binding, impurities, reference product and reference standards; finished drug product and stability.

As was the case in the previous draft guidance [1], this draft still recommends that a minimum of 10 reference product lots be used. It also recommends that a sponsor ‘include at least 6 to 10 lots of the proposed product in the comparative analytical assessment, to ensure: 1) adequate characterization of the proposed product and understanding of manufacturing variability; and 2) adequate comparison to the reference product’.

However, in contrast to the previous guidance, which required that lots come from US-sourced reference products [1], this draft allows for sponsors to use a non-US-licensed comparator in certain studies. For this to happen sponsors ‘should provide comparative analytical data and analysis for all pairwise comparisons, i.e. US-licensed product versus proposed biosimilar product, non-US-licensed comparator product versus proposed biosimilar product, and US-licensed product versus non US-licensed comparator product’.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA withdraws biosimilar statistical guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Guidelines/FDA-withdraws-biosimilar-statistical-guidance 

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