This review focuses on actions FDA, biosimilar developers and other stakeholders can take, within the boundaries of the statute, to make biosimilars more accessible. In order to first understand what is feasible for FDA and how the relevant guidelines are constructed, a review of the BPCI Act is necessary
Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(2):84-91. DOI: 10.5639/gabij.2018.0702.018
Published in: Volume 7 / Year 2018 / Issue 2