After decades of experience in taking biosimilars from cell line to market and after facing both success and failures, I feel qualified to talk about what not to do when it comes to making biosimilars accessible (available and affordable). I am inviting all of my friends (and I have many) to join me at this conference where I provide a step-by-step approach to succeeding in securing FDA approval of biosimilars. This is an experience based on a first-hand working knowledge of how the FDA lays out its expectations. I have been instrumental in contributing to FDA guidelines and detailed treatises on the science and technology of biosimilar approvals under 351k and 505b2 provisions.
A Biosimilar Delayed is a Biosimilar Denied