生物仿制药产品开发 1451条(本栏目收费,不能显示细节,电话15274084725)
US submissions,430–431 431
vs. generics physiochemical challenges,26–27 27
biosimilars approval process Canadian approval process,379 379
European approval process,390–391 391
patent exclusivities,378 378
United States approval process,383–388 388
biosimilars product development absolute change vs. relative change,5 5
aggregated vs. disaggregated criteria,5–6 6
biosimilarity index development,11–12 12
criteria for biosimilarity,4–7 7
differences from generics,3 3
drug interchangeability,10–11 11
immunogenicity problem,10 10
manufacturing process,8–9 9
moment-based criteria,6–7 7
probability-based criteria,6–7 7
statistical methods,7–8 8
biosimilars prospects for competition automatic substitution,426–427 427
biologics and innovation,417–418 418
biologics vs. chemical drugs,416–417 417
case study drug development,420 420
consumer welfare gains,434 434