Swissmedic has revised the section on the interchangeability of biosimilars. Regarding content, it continues to be the case that minor differences as a result of manufacturing processes do not affect the safety and efficacy of the biosimilar compared to the reference product.
The background to the revision is Swissmedic's experience from authorisation and market surveillance regarding the safety and efficacy of biosimilars, which confirms the results of the European Medicines Agency's broad-based analysis