From their inception, biosimilars in the U.S. have faced headwinds. Uptake has been limited. In 2018, the U.S. spent $126 billion on biologics, less than 2% of which was on biosimilars, according to IQVIA.
Legal disputes regarding originator biologic patents have impeded launches of biosimilars, some of which are stuck in patent purgatory for years following regulatory approval. Scott Gottlieb, the former FDA commissioner, has blamed sluggish uptake in part on originator companies obtaining successive patents to extend their monopolies.