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
www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm397017.pdf

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’.

Related articles
FDA issues guidance on self-identification for generics makers

FDA to publish guidance on biosimilarity and interchangeability

Reference
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

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 © 2017 Pro Pharma Communications International. All Rights Reserved.