Louise C. Druedahl receives PhD degree
On 16 February 2021, Louise C. Druedahl successfully defended her PhD thesis, entitled The current and evolving European regulation of biosimilars - views from industry and medicines agency regulators.
Regulatory approval of biosimilars, i.e., highly similar versions of originator biological products, came about to foster competition and lower drug prices; however, the degree to which these goals have been achieved varies. Biosimilars provide opportunities to relieve healthcare system budgets and increase access to medicines, but reported challenges for these products include trade secret protection and complex manufacturing processes.
The research is based within regulatory science but applies a cross-disciplinary approach by integrating knowledge about therapeutic proteins and their manufacturing, patent and trade secret protection, regulatory science, and pharmaceutical policy.
The overall aim of this thesis is to investigate how medicines agency regulators and the pharmaceutical industry view the current and future European regulatory landscape of biosimilar development and approval. The specific aims are:
- To identify key scientific, legal, and regulatory challenges in biosimilar development and their effect on biosimilar market entry (Study I).
- To determine the value and necessity of the European biosimilar clinical comparability trial requirements for establishing biosimilarity (Study II).
- To investigate the current European regulatory practices and the science underpinning interchangeability (Study III).
The conclusion of the thesis is that the European regulation of biosimilars is a success; nevertheless the participants from European national medicines agencies and the pharmaceutical industry portray a picture of biosimilars as a diverse and complex field undergoing rapid change. The current regulation may undergo changes regarding the biosimilar clinical trial requirements. Further, the European regulation of biosimilars is expected in the future to contain regulation for approval of biosimilars of recombinant orphan drugs; however, changes to the existing framework are likely to be needed for the next generation of follow-on products to gene- and cell-based therapies. Regulatory clarity on interchangeability of biosimilars would be a fruitful next step to ensure scientific grounds for either embarking on or refraining from realizing substitution of biologics in the near future.
The thesis is based on three articles, one published, and two other in preparation.
A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways
LC. Druedahl, A. Birna Almarsdóttir, S. Kälvemark Sporrong, ML. De Bruin, H. Hoogland, T. Minssen, M. van de Weert, AS. Kesselheim, A. Sarpatwari
Nature Biotechnology 38, 1253–1256 (2020).
During her time in CORS, Louise is became the recipient of an EliteForsk Travel Scholarship and took part in the 2020 Lindau Meeting. She will pursue her promising career with the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen.