termsTerm
Biosimilar
A biosimilar is a copy of a biologic drug such as trastuzumab, shown to be as safe and effective as the original once its patent expires, usually at a lower price.
Approved via abbreviated pathways (FDA 351(k), EMA) on analytical, pharmacokinetic, and comparative clinical evidence. Oncology biosimilars (trastuzumab, bevacizumab, rituximab, pegfilgrastim) now dominate volume; interchangeability designations and WHO prequalification expand access.
Regulatory: what this kind of term is about · animated schematic, not to scale
Category
Regulatory