How to start a Biosimilar development – a risk-based approach

Daniel AmstutzKnowledge, NewsLeave a Comment

Following the Biosimilar conference in Boston a few weeks ago, we would like to share our presentation on how to properly start a Biosimilar development project.
We don’t think our approach is unique, in fact far from it, as we refer to Juran’s Quality by Design concept and subsequently to the ICH guidelines Q8, 9 and 10. And we certainly don’t believe that it is the only approach to go forward.
Yet, we believe that our way of looking ahead and be prepared for obstacles is more practical, efficient and economical (in the long run) than the eyes-wide-shut-and-hope-for-the-best approach, which seems to be surprisingly more common than we have thought.