This is a busy year, as I will be presenting my newfound methodologies to take the biosimilars fast to market. I look forward to meeting my colleagues in the industry. I will be in Chicago, San Diego, Basel, China, India and Singapore, this year.
After decades of working on biosimilars, I have realized that there is a need to challenge the FDA with creative models for testing; this year I am introducing in vitro immunogenicity testing to obviate patient studies, eliminate all human trials for generic drugs and create a new pathway for substitutable biosimilars for naive patient, challenging the FDA finding that a biosimilar product has no clinically meaningful difference. I will be presenting results of my discussions with FDA.