Search – University of Copenhagen

Louise C. Druedahl

Louise C. Druedahl

PhD fellow

 

I am a PhD fellow in Regulatory Science and my PhD project is titled: Similar but not identical: the changing regulatory landscape of biosimilars from the regulator, industry, professional, and patient perspectives. See more about this below under "Current research".

 

I am affiliated to the Copenhagen Centre for Regulatory Science (CORS), see more at https://pharmacy.ku.dk/research/cors/

 

 

Research interests

So far my research interests have focused on the topics of:

  • Biosimilars from regulator, industry, clinician and patient perspectives
  • Attitudes to and experiences with taking ADHD medication
  • The pharmacy profession

I have worked with and am interested in:

  • Qualitative research
  • Sociological theories (e.g. Foucault, Medicalization/Pharmaceuticalization) 

 

Current research

My current research focuses on biosimilars and biosimilarity, which are the overall topics of my PhD project. The project title is: Similar but not identical: the changing regulatory landscape of biosimilars from the regulator, industry, professional, and patient perspectives.

 

Background 

Biosimilars are defined by the European Medicines Agency as a biological medicine highly similar to another already approved biological medicine. In 2001, the European Commission released Directive 2001/83/EC that allowed development of biosimilars to increase competitiveness and decrease healthcare costs.

It can be expected that the various stakeholders (regulators, industry, prescribers, and patients) each have their view of what is similar enough and that such views may even differ significantly within those stakeholder groups. Unfortunately, little is known about these views and how they impact the approval, development, and use of biosimilars.

 

At the industry level, “similarity” can be a contentious legal and technological issue. A biosimilar company may use processes and formulations that infringe on patent rights or trade secrets of the innovator company. The development of a biosimilar may actually result in a product that is in principle better, and the biosimilar company may have to consider whether the potential biosimilar is better off as a new product. Lastly, interchangeability and substitution guidelines differ between the EU and the US as well as within the EU countries.

 

The success of biosimilars ultimately depends on their use in practice, but research is scant on the issue of factors related to decision making about the choice of products from both the prescriber and patient perspective. Also here the concept of similarity has a certain impact since there are concerns about similar effectiveness, as well as the potential differences in formulation and device. At the same time, other incentives, including financial, play a role in market penetration of biosimilars.

 

Main areas of focus: 

  • Physicochemical biosimilarity as evaluated by industry and regulators in the EU and US.
    A questionnaire is developed in which scenarios will be devised and are varied towards increasing resemblance until the expert cannot make a choice between the scenarios.

  • Industry views on issues relating to similarity, interchangeability, IPR, trade secrets, and decisions whether to seek approval for a biosimilar or innovator drug.
    Semi-structured interviews will be conducted with industry representatives.

  • Clinician and patient perspectives about their experiences, and attitudes towards switching of biologics.
    This will be done using semi-structured interviews/focus groups.

 

See also: https://pharmacy.ku.dk/research/cors/research-projects/documents/PhD_Project_description__Biosimilars__23-01-18.pdf

ID: 169400456