FDA issues guidance on quality-related considerations for biosimilars Posted 31/05/2019

The US Food and Drug Administration (FDA) has issued draft biosimilar guidance on quality-related considerations.

The draft guidance was published in a Federal Register announcement published on 22 May 2019. It aims to assist biosimilars developers 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.

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The draft guidance is intended to replace draft guidance entitled ‘Statistical Approaches to Evaluate Analytical Similarity’. The agency withdrew the draft guidance in June 2018 after receiving public comments on the draft guidance that highlighted ‘a range of issues that could impact the cost and efficiency of biosimilar development’.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The agency says that it has ‘adjusted the title of this draft guidance to more clearly communicate that this draft guidance includes the agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed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The draft guidance outlines nine factors for consideration in performing comparative analytical assessments of biosimilars.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As was the case in the previous draft guidance [1], this draft still recommends that a minimum of 10 reference product lots be used.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’.

Related article
FDA issues final guidance on interchangeable biologicals

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 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: Federal Register

Comments (0)