EMA concept paper towards a tailored clinical approach in biosimilar development

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

EMA concept paper towards a tailored clinical approach in biosimilar development

Home/Policies & Legislation | Posted 09/02/2024 0 Post your comment

In November 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) published a 'Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development'.

This discusses the need to re-evaluate the current requirements for dedicated clinical efficacy and safety studies for biosimilars, with the aim to streamline the development and evaluation process while maintaining the highest standards of safety and efficacy.

It notes that biosimilarity of a biosimilar, as compared to a reference product, is based on a comprehensive comparability exercise comprised of Comparative Efficacy Studies (CES). The required comparability exercise comprises of quality data (analytical comparability exercise), in vitro and in vivo non-clinical data, and comparative pharmacokinetic (PK), pharmacodynamic (PD), safety and efficacy studies. However, the need for CES is increasingly questioned [1, 2] due to advances in analytical sciences and the extensive regulatory experience gained in biosimilars development.

CHMP highlights the need to keep the biosimilar pathway attractive for developers and simultaneously guarantee future access to safe and efficacious biologics for European patients.

As such, in the concept paper, CHMP notes it may be possible to further tailor the clinical approach for biosimilars and emphasizes the wealth of experience gained from previous marketing authorizations, particularly in quality comparability. They highlight that a reflection paper will be valuable to guide both developers and assessors of biosimilar medicinal products.

Further to this, the CHMP’s forthcoming reflection paper will evaluate whether or not an analytical comparability exercise, together with clinical PK/PD trials could allow for a conclusion of similarity, removing or tailoring the requirements for large Phase III studies in patients.

The public consultation on this Concept Paper started on 1 February 2024 and will run until 30 April 2024.

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Documento conceptual de la EMA hacia un enfoque clínico adaptado en el desarrollo de biosimilares

Browse the news in the Latin American Forum!

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Documento conceptual de la EMA hacia un enfoque clínico adaptado en el desarrollo de biosimilares

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. Easton RL. Front-loading biosimilar development with analytical characterization. Generics and Biosimilars Initiative Journal (GaBI Journal). 2022;11(2):82-4. doi:10.5639/gabij.2022.1102.013
2. GaBI Online - Generics and Biosimilars Initiative. WHO revised guidelines for biosimilars: scientific background [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 9]. Available from:
www.gabionline.net/biosimilars/research/who-revised-guidelines-for-biosimilars-scientific-background

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.