Rift-lines within European regulatory framework for Biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account

Master's Thesis from the year 2013 in the subject Medicine - Pharmacology, grade: 1 st CLASS HONS, Dublin Institute of Technology (Chemistry), course: Pharmaceutical Quality Assurance / Regulatory Affairs, language: English, abstract: During the course of this thesis evidence was presented and discussed related to the research questions. The fundamental question related to the heterogeneity and variation through the life cycle of the biosimilar and the reference biologic remains neglected, based on the results collected during this thesis, by the stakeholders, mainly because those issues where not addressed in any official regulatory guidance document.

As clear guidance from the EMA is lacking, with the only available guidance being that once a marketing authorization is issued it is accepted that the quality profiles of the reference biologic and the biosimilar will have different quality profiles.

Abstract:

Within the biosimilar development context, there are unaddressed questions by the European Medicines Agency (EMA) with regard to the impacts of shifts of the quality profile (purity- and impurity levels) of the reference biologic for the biosimilar development program. This dynamic is an open issues has potentially implications on the comparability exercise of the before mentioned.

Opinions from experts involved in the guidance drafting process of EMA and other were evaluated with regard to the issue.[...]