June 2024, Bonn

Amidst warm summer weather, assessors from the Biosimilar Fellowship convened this year for a two-week workshop at BfArM. This workshop is a cornerstone of the fellowship programme, offering an ideal environment for intensive learning and networking.

Building on last year’s experience, where time seemed too short for everyone, this year’s event started promptly after brief opening remarks by the project lead and BfArM experts. The first week focused on pharmaceutical quality, particularly the methodology and evaluation of comparability studies for biosimilars. In addition, the statistical methods for similarity assessment were comprehensively explored. In the second week, the emphasis was on foundational training in pharmacodynamics, especially receptor binding and activation. The training sessions led by experts from the Units 35, 23, and 54, provided diverse and practical learning experiences. Based on engaging presentations, the fellows applied and reinforced their newly acquired knowledge through hands-on group activities, including analysing parts of a dossier, questions from Scientific Advice, and practical exercises. One fellow enthusiastically shared "I loved the parts when the trainers engaged with us and did recaps after each session.”

The virtual participation in the meeting of the Committee for Medicinal Products for Human Use (CHMP), also part of this year’s programme, was highly valued. An engaging discussion on an antidiabetic drug sparked great interest: "Our involvement in the CHMP review of this antidiabetic was inspiring, educational, and enriching," noted one of the fellows.

With the toolbox from last year’s didactic training and the train-the-trainer approach, some fellows themselves took on the role of trainers. Through illustrative presentations and interactive group assignments, they delivered the fundamentals of evaluating the pharmaceutical quality of biosimilars. These training sessions are collated in a jointly developed training manual.

A highlight of the workshop was the study visit to a contract research organisation conducting clinical trial studies on diabetes treatments. Participants gained insights into techniques and devices for the glucose clamp method, which accurately and safely determines the effect of new insulins.

After two weeks of intense learning and lively exchanges, the fellows returned home highly motivated and equipped with extensive new knowledge. Post-work activities further strengthened the team spirit.