Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Interchangeability of biosimilars - comparison of EU and US perspective ***

Nicole Hauptmann (Abschlußjahr: 2019)

Summary
Language: English
Biosimilar medicinal products (‘biosimilars’) have successfully been established on the EU market for over 10 years, while introduction to the US market occurred only a few years ago. Meanwhile, the debate on biosimilars in both markets has moved on from the regulatory framework for approval to the practice of interchangeability. The issues under debate are whether biosimilars are 'interchangeable' and whether practices such as 'switching' or 'substitution' are appropriate.
The topic of interchangeability of biosimilars has raised controversy among experts and stakeholders, which is likely to have caused confusion for patients and professionals. Patient safety, market regulation and, in particular, cost saving potentials have come within the remit of this discussion.
The aim of this thesis is to address the central question of whether biosimilars can be assessed as interchangeable from a scientific point of view and whether they can be used interchangeably without compromises to patient safety. This study focuses on the highly regulated markets of the EU and the US and their respective differences concerning the interchangeability of biosimilars, which have contributed to the confusion provoked by this topic.  
In the EU, regulators have discussed the scientific rationale that endorses the interchangeability of biosimilars approved in the EU. This thesis presents these scientific considerations by describing some of the common concerns about biosimilars along with the scientific rationale to support interchangeability.
In the US, an additional approval pathway is intended for 'interchangeable biosimilars'. Draft guidance on interchangeability was published by the FDA in January 2017. This thesis considers these planned prerequisites in the FDA guideline and reflects on the current debate on this topic in the US.
Finally, the EU and US perspectives on the interchangeability of biosimilars are compared and discussed. An attempt is made to answer the questions of whether different standards exist in both markets and what it would mean to adopt a global approach on this topic.
Pages: 67  Annexes: 2, pages: 7