Position Paper

EBE Briefing Paper: Biosimilarity and Comparability after Manufacturing changes: Can a biologic become a biosimilar of itself?

22 Feb 2016
Biological medicines are derived from living organisms. Manufacturing changes can therefore have an impact on the properties of the biological medicine. This has led to questions whether a biological medicine that has undergone manufacturing changes was still the same product as the one used in the original clinical trials – or in other words: whether the respective medicine would have become a biosimilar to itself.

The regulatory basis for the assessment of a post-approval manufacturing change and for demonstration of biosimilarity is different; for the former the process is well known and extensive data is available, whereas a manufacturer of a biosimilar product will not have knowledge of the manufacturing process of the reference product hence not be able to refer to as much historical data, particularly clinical . Therefore, calling a biological medicine ‘a biosimilar of itself’ confuses the concepts of manufacturing change and biosimilarity and bears the risk to undermine trust in biological medicines and their use.

2017-09-28T14:30:06+00:00February 22, 2016|