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

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)".

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK