Approval by Authorities Does Not Allow For Suboptimal Study Conduct but Offers New Academic Possibilities

摘要

The year 2018 was the approval year of biosimilar versions of trastuzumab in Europe. While the economic advantage is clear and will be even more pronounced with presumably decreasing prices, the competition between pharmaceutical manufacturers is becoming more and more pronounced. Thus, the academic discussion ‘pro and contra’ biosimilar antibodies has shifted to ‘Which is the best biosimilar trastuzumab?’, with non-academic arguments being often used. Statements like ‘We have the longest history of protein-based products.’ or ‘Our pathological complete remission rate is clinically relevantly higher than expected.’ or ‘We are the first to produce switch data.’ are being brought forward.