European Medicines Agency Consultation: draft concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

The European Medicines Agency has recently published a draft "Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues".

The current quality guideline (EMEA/CHMP/BWP/49348/2005) was published in 2006, at a time where little experience was available on the registration of biological medicinal product claiming to be similar to another one already marketed. Significant experience has now been gained and it is recognised that the guideline needs refinements taking into account several practical considerations relating to the lifecycle (from development to product discontinuation) of similar biological medicinal products.

The document is available for consultation on the following webpage:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin...

Comments related to this concept paper should be provided using this template. The completed comments form should be sent to bwp.biosimilar.revision@ema.europa.eu.

Please note that the deadline for comments for this concept paper is 31 May 2011.

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