Regulation of Biodrugs: interchangeability, substitution & switch
Importance of control and management of the complexity of Biosimilars.
It is the tole of the authorities to study the concept of interchangeability and decide on these following comparability studies
- Comparability is demonstrated with quality and bioequivalence studies
- Question of the comparator element during comparability tests
- What are the best studies for
The decision-maker (authorities) must position himself on the question of interchangeability and the payer on the question of switch / substitution
- Importance of also implementing the tools to implement the strategy in the market, that the strategy be applicable