US biosimilar approvals poised to grow, but market uptake faces challenges, says Tufts CSDD

Biosimilar approvals in the USA are expected to increase during the next five years, but safety concerns among physicians and the need for greater regulatory clarity concerning therapeutic interchangeability could hinder market uptake, according to a study recently completed by the Tufts Center for the Study of Drug Development.

A new US regulatory pathway, called 351(k), is widely expected to speed the development and marketing of biosimilars, a process that began early this year with the first of nine biosimilars expected to gain approval by 2020, said Joshua Cohen, associate professor at Tufts CSDD and author of the study.

"Biosimilars will increase treatment options and slow the growth in spending on biologics, but lack of familiarity with biosimilars by physicians may hinder their use, as has been the case in Europe, where 17 biosimilars have been approved since 2006," Prof Cohen said.