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Biosimilars ∙ Regulatory Frameworks for Marketing Authorisation of Biosimilars: Where Do We Go From Here?

Evelien Moorkens, Arnold G Vulto, Isabelle Huys

DOI https://doi.org/10.21552/eplr/2018/3/6



Evelien Moorkens is a PhD Researcher at the Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Belgium. Prof. Arnold G. Vulto is a hospital pharmacist affiliated with the Erasmus Medical Center Rotterdam and the University of Leuven. Prof. Isabelle Huys (University of Leuven) is an expert in legal, regulatory and intellectual property rights aspects of drug development. For correspondence: <mailto:evelien.moorkens@kuleuven.be>. Isabelle Huys and Arnold Vulto are founders of the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL). Isabelle Huys and Arnold Vulto have conducted biosimilar research sponsored by Hospira (now Pfizer). Arnold Vulto is involved in consulting, advisory work and speaking engagements for a number of companies, including, AbbVie, Amgen, Biogen, EGA, Pfizer/Hospira, Mundipharma, Roche, Sandoz. The research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. This manuscript is supported by KU Leuven and the Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL). The authors would like to thank Maxine Geybels, Navjot Kaur Ghuman, Bart Leën, and Lode Vos for contacting interviewees and data collection in the context of their Master’s thesis.

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