FDA issues final guidance on pharmacology data for biosimilarity

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The US Food and Drug Administration (FDA) on 29 December 2016 published final guidance outlining the clinical pharmacology data necessary to support a biosimilar application.

Pharmacology MIT

The guidance, which replaces the draft document from May 2014, provides recommendations for what sort of clinical pharmacology studies should be used to demonstrate that there are no clinically meaningful differences between a proposed biosimilar and its reference product. According to FDA, the guidance ‘is intended to assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product’.

Clinical pharmacology data to support a demonstration of biosimilarity to a reference product
Date: December 2016

The guidance discusses some of the overarching concepts related to clinical pharmacology testing for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modelling and simulation for designing clinical trials.

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’:
• pharmacokinetic (PK) and pharmacodynamics (PD) response assessment
• evaluation of residual uncertainty
• assumptions about analytical quality and similarity

Finally, FDA reiterated that ‘these studies are part of a stepwise process for demonstrating biosimilarity between a proposed biosimilar product and the reference product’. The agency concluded by adding that ‘these studies may address residual uncertainties that remain after the analytical evaluation, may add to the totality of the evidence supporting a demonstration of biosimilarity, and may also support a selective and targeted approach to the design of any recommended subsequent clinical studies to support a demonstration of biosimilarity’.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA releases further biosimilars guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Guidelines/FDA-releases-further-biosimilars-guidance

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Source: US FDA

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