Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES
Title:
Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Guideline
Content:
This guideline addresses quality issues during demonstration of comparability for Similar Biological
Medicinal Products containing recombinant DNA-derived proteins. As a consequence, the principles
adopted and explained in this document apply to proteins and peptides, their derivatives and products
of which they are components (e.g. conjugates). For other situations see Guideline on Similar
Biological Medicinal Products, CHMP/437/04.