U.S. Biosimilar Approvals Poised to Grow, but Market Uptake Faces Challenges

Biosimilar approvals in the United States 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 U.S. 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. He added that while new biologics in the same therapeutic class could slow the adoption of biosimilar use, payers in the U.S. will encourage biosimilar prescribing by offering lower patient cost-sharing for biosimilars, compared to originator biologics, much like they do today with generic vs. name brand prescription medicines.