Change to the review practice for medicinal products containing the active substance paclitaxel as paclitaxel albumin

15.12.2025

As part of the ongoing further development of the review of medicinal products whose known active substance has a complex, heterogeneous structure, Swissmedic is adapting its review practice for new applications for medicinal products containing the known active substance paclitaxel as paclitaxel albumin (as a KAS without innovation) to the product-specific guideline of the European Medicines Agency (EMA).

The EMA guideline enters into force on 1 January 2026. Swissmedic is already following the principles it specifies and is taking these into account in the review of new applications.

Accordingly, in future, a clinical bioequivalence study can be waived for applications for new authorisation of medicinal products containing the known active substance paclitaxel albumin, provided that the analytical comparative data meet the scientific requirements in terms of quality and equivalence.

Swissmedic regularly reviews the requirements in this area and revises them when there are advances in scientific knowledge.