Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

  • Email
  • Help
Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/BWP/247713/2012
Published03/06/2014
Effective from01/12/2014
KeywordsSimilar biological medicinal product, biosimilar, recombinant proteins, quality, biosimilar comparability exercise, biosimilarity, reference medicinal product
DescriptionThis document outlines the quality requirements for a biological medicinal product claiming to be similar to another one already marketed. It covers manufacturing processes, the comparability exercise for quality, considering the choice of reference product, analytical methods, physicochemical characterisation, biological activity, purity and specifications of the similar biological medicinal product.


Document history

Revision 1

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/12/2014–present


Published: 03/06/2014


Published: 31/05/2012


Published: 22/02/2011

First versionAdopted guidelineIn operation: 01/06/2006–30/11/2014


Related content


How helpful is this page?

Average rating:

 Based on 1 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
1 ratings
    

Tell us more