Thoughts by Amgen and Pfizer on draft guidance on Biosimilars by EMA

The draft guidance on EMA stated that "scientific principles of bio similar comparability exercise are based on those applied for evaluation of the impact of changes in the manufacturing process of a biological product". This is as per Q5E guidelines.

Amgen clarified that according to them "there remains an important opportunity to be clear about the use of ICH Q5E in the bio similar comparability exercise and in the use and limitations of the principle of PD fingerprinting."Amgen also said that it needs to be recognized that ICH Q5E describes a risk assessment process that can only work for a sponsor evaluating a change to its own manufacturing process. The objective of ICH Q5E is not to provide guidance for bio similarity exercise but to provide it when changes are made in the manufacturing process for biologics. According to Amgen this fundamental difference in terms of objective/ purpose should be reflected in the final guideline.

According to Pfizer" the standard and level of evidence for bio similarity assessment must necessarily be higher since the bio similar developer have their own manufacturing process and does not therefore have access to the full development and manufacturing history which the reference product developer would have". Therefore as per Pfizer the guideline should say that the regulatory context of the assessments is "very different since ICH Q5E is meant for a manufacturer making changes to their own process. Pfizer also said that as the subject of bridging to a non-European Economic Area comparator product is discussed only in this guideline it may be helpful in providing details such as widening the scope of biological products which could be developed as biosimilars. Apart from this Pfizer also wants agency to mention cases where clinical efficacy study may not be necessary for structurally simpler biologics so that such cases would be the exception rather than the rule and should also mention how assessment of immunogenicity would be made.

EMA have acknowledged the above comments saying that the principles of bio similar and ICH Q5E may be same although the data requirements may differ.