Nigel J Rulewski
Quintiles, Inc. , USA
Title: Issues in the Clinical Development of the first Wave of Biosimilars
Biography
Biography: Nigel J Rulewski
Abstract
Biosimilars in the US are still in their infancy with only one product approved for the US market to date. However the first wave of Biosimilar products, EPO, Filgrastim, Anti TNFs and several oncology products are now well underway. The issues faced in the development of these products have evolved over time and now provide a firm basis for the next generation of biosimilar products. The issues surrounding the choice of indication in which to demonstrate biosimilarity, the basis of extrapolation and the need for transition data have all now been established. Interchangeability, a situation unique to the US approval systems still remains to be clarified, although the FDA’s likely requirements are becoming clearer. Levels of interest expressed by clinical investigators has increased significantly as the financial consequences of biosimilars become better understood. The issues encountered in the clinical development of this first wave of biosimilars and the implications of those lessons learnt for the next wave of products will be discussed.