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

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

As outlined in the Guideline on Similar Biological Medicinal Products (see News from 22 May 2013), the company that decided to develop a biosimilar must show that it will be similar in terms of Quality, Safety and Efficacy to a reference medicinal product.

Finally adopted in May and becoming effective on 1 December 2014, the FDA has now published the revised "Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)". The current guideline includes the quality requirements for a biological medicinal product claiming to be similar to another one already marketed. The document replaces the "Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (EMEA/CHMP/BWP/49348/2005)".

This guideline addresses quality aspects of the demonstration of biosimilar comparability for similar biological medicinal products containing recombinant DNA-derived proteins and derivatives to support a Marketing Authorisation Application. Nevertheless, as the biosimilar approach is accessible to any biological medicinal products, the principles explained in this document could apply to other biological products on a case by case basis.

This guideline does not address the comparability exercise for changes introduced in the manufacturing process of a given product (i.e. changes during development and post-authorisation) as outlined by ICH Q5E.

To find out more please see the complete "Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)".