EMA to launch pilot for tailored advice on biosimilars development

Biosimilares/General | Posted 03/02/2017 post-comment0 Post your comment

The European Medicines Agency (EMA) announced on 16 December 2016 that it is planning to provide sponsors with tailored scientific advice on the development of biosimilars as part of a pilot programme that will be launched in February 2017.

Conference V14A17

The European Medicines Agency (EMA) announced on 16 December 2016 that it is planning to provide sponsors with tailored scientific advice on the development of biosimilars as part of a pilot programme that will be launched in February 2017.

Specifically, the pilot will offer biosimilar developers advice on the studies and tests they should conduct, based on the available quality, analytical and functional data for the medicine. EMA expects this approach to better support the stepwise development of biosimilars, as recommended in European Union (EU) guidelines [1].

The scientific advice available currently from EMA can advise applicants on the proposed biosimilar development strategy, but does not allow for a formal assessment of data. During the pilot, an in-depth assessment of the quality, analytical and functional data will be carried out. This will enable more tailored recommendations on the studies/tests that should be carried out in the next step of the development to be given. The agency does point out, however, that ‘this will not constitute a formal pre-assessment of the data submitted during the marketing authorisation application’.

Applicants wishing to take part in the pilot must submit a briefing package and take part in a pre-submission meeting during which the suitability of the data package will be reviewed. The agency also notes that companies taking part in the pilot should count on an extra month for review in addition to normal scientific advice timelines.

EMA plans to run the pilot until six scientific advice requests have been completed, with a maximum of one scientific advice request accepted per month. The agency will then analyse the outcome of the pilot and presumably make a decision on whether to continue with this kind of advice.

Related article
EMA adopts new guidance on monitoring of biologicals

Reference
1.    GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 3]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars

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.

Source: EMA

comment icon Comments (0)
Post your comment
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010